AOCID Clinical Research Report 2014

AO Clinical Investigation and Documentation Clinical Research Report 2014

www.aocid.org

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Table of Contents Introduction..............................................................................................................................................4 AOCID ongoing studies listed on www.clinicaltrials.gov, organized by study topic ................................5 Ongoing studies – recruiting ....................................................................................................................7 Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee ................................8 PHILOS Augmented - a Multicenter Randomized Controlled Trial ....................................................15 Quadrilateral Surface Plate (QSP) Focused Registry ..........................................................................25 TMT Fusion Plate vs. Two Crossed Screws .........................................................................................31 Performance Improvement Program on Imaging II ...........................................................................37 Treatment of Medial Compartmental Osteoarthritis Grade 1-4 (Kellgren-Lawrence) or Osteonecrosis With TomoFix™ Small or Conservatively ....................................................................46 Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System (Epoca H vs T) .....................................................................................................................................53 CPP Bone Infection Registry (CPP Infection) ......................................................................................61 Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) (FR TFNA) 70 Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment ....................................................................................................................76 A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP) ...................................................................................................................................................83 Latin America Hip Fracture Mortality Study (LAMOS)........................................................................87 Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program .............................95 Focused Registry SmartFix (FRSmartFix) ..........................................................................................105 A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures (DMFx) ..........................................................................................................................................................112 MobiChina - A Prospective Multicenter Cohort Study .....................................................................120 Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures .................................................................................................................129 A Focused Registry on Anterior Cervical Interbody Spacer ACIS .....................................................137 Ongoing studies – active, not recruiting ..............................................................................................142 Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation ........................................143 Pilon Fracture Reduction and Functional Outcome .........................................................................151 Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants (Orbita 3) ..........................................................................................................................................................158 Surgical Treatment of Cervical Spondylotic Myelopathy .................................................................164 www.aocid.org

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Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India................169 AOCID publications and presentations in 2014....................................................................................175 AOCID abstracts of peer-reviewed publications in 2014 .................................................................187 Clinical Research Education by AOCID in 2014.....................................................................................215 Overview of AOCID educational events in 2014 ..............................................................................217 AOCID clinical research fellows in 2014 ...............................................................................................218 Luciano Andres Rossi, Argentina, AOTrauma Clinical Research Fellow ...........................................219 Alessandro Aprato, Italy, AOTrauma Clinical Research Fellow ........................................................223 Matheus Azi, Brazil, AOTrauma Clinical Research Fellow ................................................................224 Major AOCID-related stories on AO websites in 2014 .........................................................................225 AOCID, the first 15 years ..................................................................................................................226 AO Patient Outcomes Center ...........................................................................................................229 AO External Fixator survey is now open...........................................................................................232 AO Study Coordinator Course ..........................................................................................................234 Call for AO Clinical Study Center (AOCSC) Qualifications funded by AOTrauma .............................237 AOTrauma Course—Grant Writing...................................................................................................239 AOSpine Europe's clinical study moves ahead thanks to teamwork. Successful SCI-POEM investigator meeting in Switzerland. ................................................................................................242 AO Strategy Fund update .................................................................................................................245

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Introduction

Welcome to an expanded clinical research report by AO Clinical Investigation and Documentation (AOCID). We are proud to present you with this indispensable guide to the work conducted by AOCID and our valued network of surgeons around the world.

A quick browse through this document confirms the wide spectrum of clinical research and related subjects that AOCID has work on and published in 2014. The advantage of this electronic book is that there are many hyperlinks embedded within the text which can direct you to the source and more information.

This year, which is only our second time producing this publication, we have added the main information about our studies which is publically available on the www.clinicaltrials.gov website. You can find information on studies about to start, ones which are running and others which are still ongoing but in the analysis and publication phase.

In addition, information on our publication activities in 2014 is also presented. We have also listed 2014's non-peer reviewed publications and podium and poster presentations to give you a fuller picture of the clinical investigations and subjects that absorbed us in 2014.

Abstracts of peer-reviewed manuscripts, where available, are also reproduced here to enable you to read more about our published studies. The abstracts have been taken directly from www.pubmed.org.

This report only covers the year 2014. The current AOCID publication and presentation list can be found online. Simply visit www.aocid.org and follow the link to publications.

We hope that you enjoy this insight into the work of AOCID. Best wishes,

Andreas F채h, Director of AO Clinical Investigation and Documentation. www.aocid.org

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AOCID ongoing studies listed on www.clinicaltrials.gov, organized by study topic •

Arm Injuries 2 studies

•

Arthritis 3 studies

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Bone Diseases 4 studies

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Children's Interstitial Lung Disease 1 study

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Communicable Diseases 1 study

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Congenital Abnormalities 1 study

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Craniocerebral Trauma 1 study

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Facial Injuries 1 study

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Facies 1 study

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Femoral Fractures 5 studies

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Foot Deformities 1 study

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Foot Deformities, Congenital 1 study

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Forearm Injuries 1 study

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Fractures, Bone 11 studies

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Fractures, Closed 1 study

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Hallux Valgus 1 study

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Hip Fractures 5 studies

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Hip Injuries 5 studies

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Humeral Fractures 1 study

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Infection 1 study

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Jaw Fractures 1 study

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Joint Diseases 3 studies

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Leg Injuries 5 studies

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Mandibular Fractures 1 study

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Maxillofacial Injuries 1 study

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Muscle Rigidity 1 study

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Musculoskeletal Diseases 5 studies

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Necrosis 2 studies

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Osteoarthritis 3 studies

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Osteoarthritis, Knee 2 studies

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Osteomyelitis 1 study

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Osteonecrosis 2 studies

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Osteoporotic Fractures 1 study www.aocid.org

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Pain 1 study

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Quality of Life 3 studies

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Radius Fractures 1 study

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Rheumatic Diseases 3 studies

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Scoliosis 1 study

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Skull Fractures 1 study

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Spinal Curvatures 1 study

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Spinal Diseases 1 study

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Tibial Fractures 1 study

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Wounds and Injuries 10 studies

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Ongoing studies – recruiting

www.aocid.org

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Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee This study is currently recruiting participants. (see Contacts and Locations) Verified January 2015 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02077647 First received: February 12, 2014 Last updated: January 13, 2015 Last verified: January 2015 Purpose The primary objective of this registry is to assess the functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated conservatively. The aim of the Focused Registry is to complete the data collection and enable a sound analysis for the Tomofix Small size study.

Condition Osteoarthritis, Knee Osteonecrosis

Study Type:

Observational [Patient Registry]

Study Design:

Observational Model: Case Control Time Perspective: Prospective

Target Follow-Up Duration: 24 Months Official Title:

A Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee

Resource links provided by NLM: MedlinePlus related topics: Osteoarthritis Osteonecrosis www.aocid.org

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U.S. FDA Resources Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Function of the knee [ Time Frame: 24 months ] [ Designated as safety issue: No ] Knee Injury and Osteoarthritis Outcome Score (KOOS) Secondary Outcome Measures:

•

Patient-evaluated function of the knee and quality of life [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ] Oxford-12-item knee score, WOMAC (as calculated from the KOOS)

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Clinician-evaluated function of the knee [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ] Japanese Orthopaedic Association (JOA) score

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Health-related quality of life [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ] Short Form-36 (SF-36)

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Range of motion (ROM) [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

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Local and general pain [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ] Visual Analogue Scale (VAS)

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Possibility and duration of the Japanese sitting style [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

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Return to sport activities [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

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Utilization [ Time Frame: up to hospital discharge ] [ Designated as safety issue: No ] Length of hospital stay www.aocid.org

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Evaluation of degenerated and regenerated cartilage [ Time Frame: intraoperative and after 2 years ] [ Designated as safety issue: No ] ICRS and Outerbridge / Koshino)

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Radiological parameters [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ] Kellgren-Lawrence classification, joint space narrowing, tibial slope, tibia vara

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Complications [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ] Complications due to injections, complications due to heat therapy, complications due to medication (NSAIDs)

•

Anatomical alignment [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ] Femoro tibial angle (FTA)

Estimated Enrollment:

20

Study Start Date:

March 2014

Estimated Study Completion Date:

February 2017

Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure) Groups/Cohorts Conservative Conservative treatment of osteoarthritis of the knee Detailed Description: The aim of the Focused Registry is to complete the data collection and enable a sound analysis for the Tomofix Small size study.

The incidence of knee osteoarthritis (OA) is higher in Japan than in other populations.

Respective prevalences of 47.0 and 70.2% in men and women for Kellgren-Lawrence Grades 2-4 knee OA are reported in Japanese patients aged 60 years and over. www.aocid.org

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First treatment options are pharmacological (i.e. NSAIDs) and non-pharmacological therapies (i.e. use of assistive devices, exercises, osteopathy, physical therapy), followed by injections of hyaluronic acid and other substances. If no such therapies are successful, surgical treatment options as unicompartmental knee replacement, total knee arthroplasty and high tibial osteotomy (HTO) are recognized. The discussion of which is the best therapy is still controversial. HTO may decrease the number of complications compared to total knee replacement or unicompartmental knee arthroplasty and leave the option for later replacement surgery.

In this project, patients are included who would be surgically treated with HTO with Tomofix small based on the investigator's assessment but refuse to have surgical treatment. They will be treated conservatively and are investigated to serve as reference to an ongoing clinical study investigating invasive treatment modalities.

Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: Sampling Method:

40 Years and older Both No Non-Probability Sample

Study Population Patients with Indication for open wedge HTO with the TomoFix™ Small presenting in the orthopaedic department of the participating hospitals Criteria Inclusion Criteria: •

40 years of age and older

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Patients with OA Grade 1-4 (Kellgren-Lawrence) or osteonecrosis (ON) Stage 2-4 (according to the Koshino classification)

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Indication for open wedge HTO with the TomoFix™ Small

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No ligamental laxity

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Able to understand and read country national language at an elementary level

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Ability to understand the content of the patient information / informed consent form

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Willingness and ability to participate in the registry according to the registry plan (RP)

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Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria: www.aocid.org

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Femoro-tibial angle (FTA) > 190° (standing view x-ray)

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Flexion contracture > 15°

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Total knee replacement or unicompartmental knee on the contralateral side

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Infections located between the middle of the femur and the ankle

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Systemic bacterial infections

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Severe osteoarthritis or surgery of the hip joint

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Smoking of more than 20 cigarettes per day

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Immunodeficiency or compromised host

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Patients who have participated in any other device or drug related clinical trial within the previous month

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ACL/PCL reconstruction of the same knee

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Severe osteoarthritis of the ipsilateral ankle joint

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HTO on the contralateral side

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Major surgery on both knees (minor surgery as arthroscopic meniscectomy and synovectomy is allowed) Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT02077647 Contacts Contact: Jan Ljungqvist

+41 (0) 44 200 24 61

jan.ljungqvist@aofoundation.org

Locations Japan Nagasaki University Recruiting Nagasaki city, Japan, 852-8501 Contact: Akihiro Yonekura, MD +81 (0) 95 819 7321 yonekura@nagasakiu.ac.jp Principal Investigator: Akihiro Yonekura, MD Osaka Koseinenkin Hospital Recruiting Osaka, Japan, 553-0003 Contact: Yuzo Yamada, MD +81 (0) 6 6441 5451 yamadayuzo@umin.ac.jp Principal Investigator: Yuzo Yamada, MD Hashiba Orthopaedic Clinic

Recruiting www.aocid.org

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Toyama-city, Japan, 939-8055 Contact: Kensaku Hashiba, MD +81(0)76 423 5580 hashiba@po1.dti2.ne.jp Principal Investigator: Kensaku Hashiba, MD Toyama Municipal Hospital Recruiting Toyama-city, Japan, 939-8511 Contact: Takeshi Sawaguchi, MD +81 (0) 76 422 1112 sawaguch@mxq.mesh.ne.jp Principal Investigator: Takeshi Sawaguchi, MD Sponsors and Collaborators AO Clinical Investigation and Documentation Investigators Study Director:

Beate P. Hanson, MD

AO Clinical Investigation and Documentation, Davos, Switzerland

Principal Investigator:

Takeshi Sawaguchi, MD

Toyama Municipal Hospital, Toyama-city, Japan

More Information Publications: Takeuchi R, Aratake M, Bito H, Saito I, Kumagai K, Hayashi R, Sasaki Y, Akamatsu Y, Ishikawa H, Amakado E, Aota Y, Saito T. Clinical results and radiographical evaluation of opening wedge high tibial osteotomy for spontaneous osteonecrosis of the knee. Knee Surg Sports Traumatol Arthrosc. 2009 Apr;17(4):361-8. doi: 10.1007/s00167-008-0698-4. Epub 2009 Jan 23.

Takeuchi R, Ishikawa H, Aratake M, Bito H, Saito I, Kumagai K, Akamatsu Y, Saito T. Medial opening wedge high tibial osteotomy with early full weight bearing.

Arthroscopy. 2009 Jan;25(1):46-53. doi: 10.1016/j.arthro.2008.08.015. Epub 2008 Oct 10.

Takeuchi R, Saito T, Koshino T. Clinical results of a valgus high tibial osteotomy for the treatment of osteoarthritis of the knee and the ipsilateral ankle. Knee. 2008 Jun;15(3):196-200. doi: 10.1016/j.knee.2008.02.002. Epub 2008 Mar 25.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02077647 Other Study ID Numbers:

FR_Tomofix

www.aocid.org

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Study First Received:

February 12, 2014

Last Updated:

January 13, 2015

Health Authority:

Japan: Ministry of Health, Labor and Welfare

Keywords provided by AO Clinical Investigation and Documentation: Knee osteoarthritis knee osteonecrosis osteotomy Additional relevant MeSH terms: Osteoarthritis Osteoarthritis, Knee Osteonecrosis Arthritis Bone Diseases

Joint Diseases Musculoskeletal Diseases Necrosis Pathologic Processes Rheumatic Diseases

ClinicalTrials.gov processed this record on February 12, 2015.

www.aocid.org

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PHILOS Augmented - a Multicenter Randomized Controlled Trial This study is currently recruiting participants. (see Contacts and Locations) Verified January 2015 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01847508 First received: April 26, 2013 Last updated: January 13, 2015 Last verified: January 2015 Purpose The primary objective is to compare the mechanical failure risks in the first year after treatment.

Condition

Intervention

Phase

Humerus Fractures Closed Fracture of the Proximal Humerus

Device: PHILOS+ Device: PHILOS

Phase 4

Study Type:

Interventional

Study Design:

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Official Title:

A Multicenter Randomized Controlled Trial to Investigate the Treatment Outcome of PHILOS Screw Augmentation Compared to PHILOS Without Augmentation in Older Adult Patients With Proximal Humerus Fractures

Resource links provided by NLM: MedlinePlus related topics: Arm Injuries and Disorders Fractures U.S. FDA Resources www.aocid.org

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Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Any occurrence of radiographically confirmed mechanical failure during the first year after treatment. [ Time Frame: one year ] [ Designated as safety issue: No ] Mechanical failures are defined as loss of reduction (≥ 15° increase of varus malposition between the immediate postoperative position and follow-up radiograph, relative change [5 mm] of greater or lesser tuberosity compared to the immediate postoperative position), head impaction (≥ 5 mm difference in outer plate edge and tangent of humeral head between immediate post-op and follow-up. The tangent is determined perpendicular to the humeral neck), screw/plate loosening (any change outwards of screw position in relation to immediate postoperative position) and secondary screw perforation (perforation of one or more screws through the humeral head into the joint space on the follow-up radiograph(and lack of screw perforation on the intra- or postoperative Rx based on a baseline anteroposterior and axial Rx.

Secondary Outcome Measures: •

Quality of life [ Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery ] [ Designated as safety issue: No ] EuroQol-5D (EQ-5D).

•

Intra- and postoperative adverse events related to the procedure and/or device [ Time Frame: Up to one year ] [ Designated as safety issue: No ] Implant/surgery , Bone/fracture, Soft tissue of the musculoskeletal system, Wound/other local tissue, Systemic/rest of the body.

•

Reoperation rate [ Time Frame: Up to one year ] [ Designated as safety issue: No ]

•

Surgical details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ] Surgery duration (skin to skin in min).

•

Description of augmentation details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ] www.aocid.org

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Number of screws augmented.

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Surgical details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ] Time of day of surgery.

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Surgical details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ] Number and position of screws used.

•

Surgical details [ Time Frame: Intra- /postoperative ] [ Designated as safety issue: No ] Anatomic/non-anatomic reduction.

•

Surgical details [ Time Frame: Intra- /postoperative ] [ Designated as safety issue: No ] Restoration of medial support.

•

Description of augmentation details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ] Number of incidences of direct contrast fluid leakage.

•

Description of augmentation details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ] Augmentation-related adverse events and their association with fracture characteristics.

•

Description of augmentation details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ] Volume of injected cement (in ml).

•

Shoulder function [ Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery ] [ Designated as safety issue: No ] Shoulder Pain and Disability Index (SPADI).

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•

Shoulder function [ Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery ] [ Designated as safety issue: No ] Constant score.

•

Shoulder function [ Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery ] [ Designated as safety issue: No ] Disabilities of the Arm, Shoulder and Hand Score (QuickDASH).

•

Relation of patient factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ] Comorbidity.

•

Relation of patient factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ] Mental health with Mini Mental State Examination (MMSE).

•

Relation of patient factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ] Bone mineral density (BMD) measured with CT.

•

Relation of fracture characteristics on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ] Number of fracture parts.

•

Relation of fracture characteristics on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ] Severity of displacement.

•

Relation of fracture characteristics on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ] Varus/valgus.

•

Relation of surgical factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ] www.aocid.org

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Anatomic/non-anatomic reduction (varus, anteversion etc.). •

Relation of surgical factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ] Restoration of medial support.

•

Relation of surgical factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ] Time of surgery.

Estimated Enrollment:

128

Study Start Date:

October 2013

Estimated Study Completion Date:

September 2016

Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure) Arms

Assigned Interventions

Active Comparator: PHILOS + Proximal Humeral Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).

Device: PHILOS+ Proximal Humerus Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).

Other Names: PHILOS Length 90 mm with 3 shaft holes PHILOS Length 114 mm with 5 shaft holes

Active Comparator: PHILOS Proximal Humeral Internal Locking System (PHILOS)

Device: PHILOS Proximal Humerus Internal Locking System (PHILOS).

Other Names:

www.aocid.org

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PHILOS Length 90 mm with 3 shaft holes PHILOS Length 114 mm with 5 shaft holes

Detailed Description: Biomechanical tests have shown that augmentation of screws or nails with polymethylmethacrylate (PMMA) leads to increased mechanical properties of the bone-implant complex, leading to the assumption that augmentation could reduce mechanical failures in patients. While a few clinical studies have already been performed with augmented trochanteric nails in proximal femur fractures, no clinical studies exist with the use of Proximal Humerus Internal Locking System (PHILOS) and (PMMA) augmentation for the treatment of fractures in the proximal humerus.

In this study a new standardized technique for augmentation of screw tips using high viscous PMMA cement (Traumacem V+) with the PHILOS plate will be applied.

Fracture treatment with PHILOS Screw Augmentation will be compared with treatment with PHILOS without augmentation.

Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers:

65 Years and older Both No

Criteria Inclusion Criteria: •

Age ≥ 65 years

•

Low energy trauma (e.g. fall from standing height)

•

Radiologically confirmed closed fracture (≤ 10 days) of the proximal humerus

•

Any displaced or unstable 3- or 4-part fracture of the proximal humerus (i.e. segment dis-placement > 0.5 cm or angulated > 45°) except isolated displaced fractures of the greater or lesser tuberosity

•

Primary fracture treatment with a PHILOS plate

•

Ability to understand the content of the patient information / informed consent form

•

Willingness and ability to participate in the clinical investigation including imaging and fol-low-up procedures

•

Signed informed consent

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Preoperative Exclusion Criteria: •

Bilateral or previous proximal humerus fractures on either side

•

Splitting fracture of the humeral head or humeral head impression fracture

•

Cuff-arthropathy of the contra- or ipsilateral proximal humerus

•

Associated nerve or vessel injury

•

Any known clotting disorders, severe cardiac and/or pulmonary insufficiency

•

Known hypersensitivity or allergy to any of the components of Traumacem V+ Cement Kit

•

Any severe systemic disease: class 4 - 6 of the American Society of Anesthesiologists (ASA) physical status classification

•

Any not medically managed severe systemic disease: class 3 of the ASA physical status classification

•

Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment

•

Prisoner

•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Intraoperative Exclusion Criteria: •

Intraoperative decision to use implants other than PHILOS/PHILOS Screw Augmentation Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01847508 Contacts Contact: Jan Ljungqvist

+41 44 200 24 61

jan.ljungqvist@aofoundation.org

Locations Austria Medical University of Innsbruck Innsbruck, Austria, 6020 Contact: Franz Kralinger, MD

Recruiting

www.aocid.org

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Principal Investigator: Franz Kralinger, MD Belgium UZ Leuven Recruiting Leuven, Belgium, 3000 Contact: Stefaan Nijs, M.D. Principal Investigator: Stefaan Nijs, MD Germany University Hospital RWTH Aachen Not yet recruiting Aachen, Germany, 52074 Contact: Gertraud Gradl, MD Principal Investigator: Gertraud Gradl, MD University Medical Center Freiburg Recruiting Freiburg, Germany, 79095 Contact: Norbert Südkamp, MD Principal Investigator: Norbert Südkamp, MD Sub-Investigator: Martin Jaeger, MD Saarland University Medical Center Not yet recruiting Homburg, Germany, 66421 Contact: Tim Pohlemann, MD Principal Investigator: Tim Pohlemann, MD Sub-Investigator: Jörg Holstein, MD BG Clinic Ludwigshafen Not yet recruiting Ludwigshafen, Germany, 67071 Contact: Jochen Franke, MD Principal Investigator: Jochen Franke, MD Sub-Investigator: Marc Schoen, MD Sub-Investigator: Daniel Matte, MD Sub-Investigator: Philipp von der Linden, MD BG Clinic Tübingen Recruiting Tübingen, Germany, 72076 Contact: Christian Bahrs, MD Principal Investigator: Christian Bahrs, MD Sub-Investigator: Tim Klopfer, MD Sub-Investigator: Simon Scheiderer, MD Switzerland Cantonal Hospital Lucerne Lucerne, Switzerland, 6000

Recruiting

www.aocid.org

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Contact: Reto Babst, MD Principal Investigator: Reto Babst, MD Sub-Investigator: Alexander Brunner, MD Triemli hospital Recruiting ZĂźrich, Switzerland, 8063 Contact: Andreas Platz, MD Principal Investigator: Andreas Platz, MD Sub-Investigator: Mario Rancan, MD Sub-Investigator: Ăœnal Can, MD Sponsors and Collaborators AO Clinical Investigation and Documentation Investigators Study Director:

Beate P. Hanson, MD

AO Clinical Investigation and Documentation, Davos, Switzerland

Principal Investigator:

Franz Kralinger, MD

Medical University of Innsbruck, Austria

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01847508 Other Study ID Numbers:

PHILOS+

Study First Received:

April 26, 2013

Last Updated:

January 13, 2015

Health Authority:

Austria: Ethikkommission Belgium: Ethics Committee Germany: Ethics Commission Switzerland: Ethikkommission

Additional relevant MeSH terms: Fractures, Bone Fractures, Closed Humeral Fractures Arm Injuries Wounds and Injuries

Cardiovascular Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses www.aocid.org

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Polymethyl Methacrylate Antimutagenic Agents

Vasodilator Agents

ClinicalTrials.gov processed this record on February 12, 2015.

www.aocid.org

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Quadrilateral Surface Plate (QSP) Focused Registry This study is currently recruiting participants. (see Contacts and Locations) Verified January 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01839565 First received: April 12, 2013 Last updated: January 16, 2014 Last verified: January 2014 Purpose The absence of methodologically, prospectively and retrospectively collected information on the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a multicenter approach. Using a registry to get more information about the effectiveness and possible benefits or complications during the surgery and during the post-operative treatment is adequate and necessary to get new insights to the use of the Quadrilateral Surface Plate.

Condition Acetabular Fracture

Intervention Device: Quadrilateral Surface Plate

Study Type:

Observational [Patient Registry]

Study Design:

Observational Model: Case-Only Time Perspective: Prospective

Target Follow-Up Duration: 24 Months Official Title:

A Prospective and Retrospective Multicenter Registry for Surgeon-based Evaluation of the "Quadrilateral Surface Plate" Used for Acetabular Fractures

Resource links provided by NLM: MedlinePlus related topics: Fractures

www.aocid.org

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U.S. FDA Resources Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Surgical treatment-related Adverse Events [ Time Frame: Intra-operative ] [ Designated as safety issue: No ] Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.

Secondary Outcome Measures:

•

Changes in Quality of Life [ Time Frame: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative ] [ Designated as safety issue: No ] Changes in Quality of Life, pain and mobility using questionnaires (EQ-5D and Merle d'Aubigné score)

•

Fracture Healing [ Time Frame: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative ] [ Designated as safety issue: No ] Fracture healing: defined as a fracture radiographically showing at least three cortices with signs of callus or trabeculae crossing from one side of the fracture to the other.

•

Surgical treatment-related Adverse Events till discharge [ Time Frame: postoperative ] [ Designated as safety issue: No ] Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 1-12 days postoperative (till discharge)

•

Surgical treatment-related Adverse Events till 6 weeks [ Time Frame: post-operative ] [ Designated as safety issue: No ] Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 6 weeks postoperative

•

Surgical treatment-related Adverse Events till 3 months [ Time Frame: postoperative ] [ Designated as safety issue: No ] www.aocid.org

26

Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 3 months postoperative

•

Surgical treatment-related Adverse Events till 6 months [ Time Frame: postoperative ] [ Designated as safety issue: No ] Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 6 months postoperative

•

Surgical treatment-related Adverse Events till 12 months [ Time Frame: postoperative ] [ Designated as safety issue: No ] Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 12 months postoperative

•

Surgical treatment-related Adverse Events till 24 months [ Time Frame: postoperative ] [ Designated as safety issue: No ] Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 24 months postoperative

Estimated Enrollment:

40

Study Start Date:

October 2012

Estimated Study Completion Date:

March 2018

Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure) Groups/Cohorts

Assigned Interventions

Patients Patients undergoing osteosynthesis of acetabular fractures by using the Quadrilateral Surface Plate

Device: Quadrilateral Surface Plate Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate

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Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Sampling Method: Probability Sample Study Population The increasing number of acetabular fractures in elderly individuals with osteoporosis has added new technical challenges to surgical management. A common group of fracture patterns in this population is the anterior wall or column often with an associated posterior hemitransverse.

These injuries frequently also include quadrilateral surface comminution which can make both reduction and stabilization more difficult. The 3.5 mm quadrilateral surface plate was developed to provide a more effective way to deal with these issues, for example, a way to deal with the quadrilateral surface enbloc for reduction, allowing buttress stabilization, which is independent of bone density.

Criteria Inclusion Criteria: •

Age 18 years or older

•

Diagnosis of acetabular fracture requiring surgical fixation

•

Ability to understand the content of the patient information / informed consent form

•

Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria: •

Any not medically managed severe systemic disease

•

Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

•

Prisoner

•

Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry

Intraoperative exclusion criteria: •

Intraoperative decision to use implants other than the device under investigation

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Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01839565.

Locations Germany Berufsgenossenschaftliche Unfallklinik Frankfurt am Recruiting Main Frankfurt, Germany, 60389 Contact: Reinhard Hoffmann, Prof. MD Reinhard.Hoffmann@bgufrankfurt.de Principal Investigator: Reinhard Hoffmann, Prof. MD Universitaetsklinikum Heidelberg

Not yet recruiting

Heidelberg, Germany, 69118 Contact: Gerhard Schmidmaier, Prof. MD +49 1622 999 553 gerhard.schmidmaier@med.uni-heidelberg.de Principal Investigator: Gerhard Schmidmaier, Prof. MD University of Saarland Recruiting Homburg/Saar, Germany, 66421 Contact: Tim Pohlemann, Prof. MD +496841163 ext 1502 tim.pohlemann@uks.eu Principal Investigator: Tim Pohlemann, Prof. MD Klinikum der Johannes Gutenberg Universitaet Mainz Recruiting Mainz, Germany, 55131 Contact: Pol M. Rommens, Prof. MD +49 6131 17 72 92 rommens@unfall.klinik.uni-mainz.de Principal Investigator: Pol M. Rommens, Prof. MD Italy Not yet recruiting

Ortopedia e Traumatologia Rome, Italy, 00165 Contact: Michel Oransky, Prof. MD +39 349 2379930 oransky103@gmail.com Principal Investigator: Michel Oransky, Prof. MD Switzerland Luzerner Kantonsspital Luzern, Switzerland, 6000

Recruiting

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Contact: Reto Babst, Prof. MD +41 205 48 82 reto.babst@luks.ch Principal Investigator: Reto Babst, Prof. MD Sponsors and Collaborators AO Clinical Investigation and Documentation Investigators Principal Investigator:

Tim Pohlemann, Prof. MD AO foundation

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01839565 Other Study ID Numbers:

FR_QSP

Study First Received:

April 12, 2013

Last Updated:

January 16, 2014

Health Authority:

Germany: Ethics Commission Italy: Ethics Committee Switzerland: Ethikkommission United States: Institutional Review Board

Keywords provided by AO Clinical Investigation and Documentation: Adverse events Osteosynthesis Quality of life Additional relevant MeSH terms: Fractures, Bone Wounds and Injuries ClinicalTrials.gov processed this record on February 12, 2015.

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TMT Fusion Plate vs. Two Crossed Screws This study is currently recruiting participants. (see Contacts and Locations) Verified January 2015 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02096146 First received: March 21, 2014 Last updated: January 21, 2015 Last verified: January 2015 Purpose This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly assigned to one of these two treatment options.

Condition

Intervention

Clinical Indication for First Metatarsal Joint Arthrodesis

Procedure: TMT Fusion plate Procedure: Two crossed screws

Study Type:

Interventional

Study Design:

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Official Title:

TMT Fusion Plate vs. Two Crossed Screws - A Randomized Controlled Trial

Further study details as provided by AO Clinical Investigation and Documentation:

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31

Primary Outcome Measures: •

Change in the patient-reported MOXFQ [ Time Frame: Up to 4 weeks pre-operative, Discharge (up to 1 week post-operative), 2 week FU, 6 week FU, 3 month FU, 6 month FU, 12 month FU ] [ Designated as safety issue: No ] Outcome measures for the study focus on fully validated patient related outcome measures for the foot (MOXFQ).

Secondary Outcome Measures:

•

Development of bone healing assessed based on x-rays [ Time Frame: 6 and 12 weeks postoperative ] [ Designated as safety issue: No ]

•

Reconstruction of the joint position based on x-rays [ Time Frame: Pre-operative up to 4 weeks vs. post-operative up to 2 weeks ] [ Designated as safety issue: No ]

•

Change in quality of life (EQ-5D) [ Time Frame: Up to 4 weeks pre-operative, discharge (up to 1 week post-op), 2 weeks FU, 6 weeks FU, 3 months FU, 6 months FU, 12 months FU ] [ Designated as safety issue: No ] Outcome measure of general health

•

Weekly assessed weight bearing during weeks 6-12 [ Time Frame: 3 months FU ] [ Designated as safety issue: No ]

•

Complications related to implant or surgery [ Time Frame: Starts with surgery and is continued until the end of the study (12 months FU) ] [ Designated as safety issue: No ] For the duration of the study complications are continuously recorded and not restricted to the defined follow up visits.

•

Documentation of medication and treatment costs [ Time Frame: Starts after surgery and is continued until the end of the study (12 months FU) ] [ Designated as safety issue: No ] A cost diary to collect treatment costs is distributed and collected at the next FU visit.

Estimated Enrollment:

148

Study Start Date:

October 2014

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Estimated Study Completion Date:

September 2016

Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure) Arms

Assigned Interventions

TMT Fusion Plate Patients are treated with TMT Fusion Plate to encourage bony fusion of the 1st TMT joint.

Procedure: TMT Fusion plate Patients are treated with TMT Fusion Plate a post-market device to encourage bony fusion of the 1st TMT joint.

Two crossed screws Patients are treated with two crossed screws. This procedure is a standard treatment for 1st TMT joint fusion.

Procedure: Two crossed screws Patients are treated with two crossed screws. This procedure is a standard treatment for 1st TMT joint fusion.

Detailed Description: Tarsometatarsal joint arthrodesis is a common procedure which can be performed using various devices such as screws, plates or both. The Tarsometatarsal Fusion Plate from "DePuySynthes" is a new device designed to encourage bony fusion of the 1st TMT joint, and is expected to lead to earlier fusion compared to the current standard of care of using 2 crossed screws. This is expected, in turn, to result in an earlier reduction in pain and an earlier return to full activity. At this time there is insufficient data directly comparing outcome following surgery for patients treated with screws or plates, and a study protocol which produces a higher level of evidence is therefore necessary.

The main aim of this study is to compare patient-reported outcome following surgery for patients undergoing joint arthrodesis using the TMT Fusion plate versus screws only. It is expected that surgery will improve patient-reported outcome similarly for both treatment groups in the long-term, but that the improvement will occur earlier for the plate group. For this study patient-reported outcome will be assessed by the walking/standing and pain domain scores of the Manchester Oxford Foot Questionnaire (MOXFQ). An earlier improvement in any of these two domains would be considered to be valuable. The primary analysis will therefore compare the time to a minimal clinically relevant improvement for any of the two MOXFQ domains for patients treated with TMT fusion plate versus patients treated with only screws during the first 12 months following surgery.

An economic evaluation from a societal perspective will determine the incremental cost-effectiveness of the TMT fusion plate versus the 2 crossed screws technique for

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1st TMT joint fusion. Therefore a randomized controlled trial will be conducted, where patient-reported outcomes as well as clinical outcome parameters will be assessed.

Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers:

18 Years to 65 Years Both No

Criteria Inclusion Criteria: •

Age: between 18 and 65 years

•

At least one of the following:

o

1st TMT arthritis

o

hallux valgus (intermetatarsal angle (IM) 1-2 angle > 15° on plain x-ray)

o

1st ray hypermobility with or without flat foot

•

Painful condition

•

Ability to understand the content of the patient information / Informed Consent Form

•

Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)

•

Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria: •

Active infection

•

Previous surgery on the 1st ray of the same foot

•

Previous non-union on the 1st ray of the same foot

•

Clinical obvious arthritis in other joints of the lower extremities

•

Purely seeking plastic surgery

•

Peripheral vascular disease (e.g. advanced diabetes)

•

Peripheral sensory neuropathy (e.g. advanced diabetes)

•

Concurrent surgery of the contralateral foot

•

Any previously medically unmanaged severe systemic disease

•

Substance abuse that would preclude reliable assessment

•

Prisoner

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•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT02096146.

Contacts Contact: Katrin Stadelmann, PhD

+41 81 414 25 09

katrin.stadelmann@aofoundatio n.org

Contact: Andreas Faeh

+41 44 200 24 67

andreas.faeh@aofoundation.org

Locations United States, Michigan Mid Michigan Orthopedic Institute - East Lansing Recruiting East Lansing, Michigan, United States, 48823 Contact: Michael Swords 517-333-3777 foot.trauma@gmail.com Principal Investigator: Michael Swords United States, Minnesota Summit Orthopedics Not yet recruiting Woodbury, Minnesota, United States, 55125 Contact: Michael Castro 480-290-9116 michael.castro@me.com Principal Investigator: Michael Castro United States, New York NY Downtown Orthopedic Associates Not yet recruiting New York, New York, United States, 10038 Contact: Andrew K. Sands 212-312-5966 aksands@gmail.com Principal Investigator: Andrew K. Sands Colombia Centro MĂŠdico Imbanaco Cali Recruiting Cali, Colombia, 233 Contact: Juan B. Gerstner 57-2-6821000 jbgerstner@me.com Principal Investigator: Juan B. Gerstner

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United Kingdom Ian Winson Not yet recruiting Bristol, United Kingdom, BS10 5NB Contact: Ian Winson, MB ChB, FRCS +44 117 959 51 97 ianwinson@doctors.org.uk Principal Investigator: Ian Winson Sponsors and Collaborators AO Clinical Investigation and Documentation Investigators Principal Investigator:

Ian Winson, MB ChB, FRCS

Southmead Hospital

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02096146 Other Study ID Numbers:

TMT Fusion Plate

Study First Received:

March 21, 2014

Last Updated:

January 21, 2015

Health Authority:

United Kingdom: Research Ethics Committee United Kingdom: National Health Service United States: Institutional Review Board Colombia: Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation: Plate Hallux valgus Foot deformity

Screw Tarsometatarsal angle Cost effectiveness

ClinicalTrials.gov processed this record on February 12, 2015.

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Performance Improvement Program on Imaging II This study is not yet open for participant recruitment. (see Contacts and Locations) Verified October 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02272972 First received: October 10, 2014 Last updated: October 21, 2014 Last verified: October 2014

Purpose This study consists of a retrospective and a prospective part. For each part and in each of 5 clinics, one intraoperative post-implant image (lateral view) of 25 patients with pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two assessments in the retrospective part. a) before an educational intervention, b) after the educational intervention. The evaluated images at these two time points are identical. In the prospective part, the surgeons apply their new knowledge from the educational intervention. They perform the positioning of the patient during the intraoperative fluoroscopy and record the image according to the teaching material.

One post-implant image of each patient will be used for the evaluation.

At all three time points of image assessment, a questionnaire with the same set of 7 criteria (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the educational material.

Condition Hip Fractures Femoral Fractures

Intervention Other: Application of knowledge

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Fractures, Bone

Study Type:

Observational

Official Title:

Performance Improvement Program on Imaging II

Resource links provided by NLM: MedlinePlus related topics: Fractures Hip Injuries and Disorders Leg Injuries and Disorders U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Image quality as determined by The proportion of "yes" answers to Q1 and Q2 in the post-educational assessment II compared to the proportion of "yes" answers to Q1 and Q2 pre-educational assessment. [ Time Frame: 6 months ] [ Designated as safety issue: No ] Secondary Outcome Measures:

•

Interrater agreement between pre-educational and post-educational assessment of image quality (Q1-Q2) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

•

Proportion of images that are rated as "not assessable" (Q3-Q7) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

•

Proportion of "Quality of reduction and surgery" criteria with the best possible assessment (yes/optimal) (Q3-Q7) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

•

Interrater agreement between pre-educational and post-educational assessment of surgery's quality (Q3-Q7) [ Time Frame: 6 months ] [ Designated as safety issue: No ] www.aocid.org

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•

Surgeons' experience (years and professional level) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

•

Surgeons practice (average number of hip surgeries per month) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

•

Self-assessment gap score [ Time Frame: 6 months ] [ Designated as safety issue: No ] (3 questions regarding the current and the desired level of ability in fixing pertrochanteric femoral fractures, obtaining lateral intraoperative images of the proximal femur and assessing lateral intraoperative images of the proximal femur)

Estimated Enrollment:

250

Study Start Date:

October 2014

Estimated Study Completion Date:

November 2015

Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure) Groups/Cohorts

Assigned Interventions

Retrospective group One x-ray image per patient is assessed by the surgeon. The surgeon undergoes an educational intervention (video/poster) and applies the achieved knowledge during the second assessment of the same image. The intervention is not administered to patients, only to an image.

Prosp.group (Application of knowledge)

Other: Application of knowledge

No direct intervention at the patient. The surgeon applies the achieved knowledge

Educational Intervention has been performed at the treating surgeon

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during the performance of the fluoroscopy in the operating room. This image is assessed.

(video and poster). The surgeon applies the achieved knowledge when performing the intraoperative fluoroscopy in patients with pertrochanteric fractures.

Detailed Description: 5 surgeons in 5 clinics will participate including a total of 125 prospective and 125 retrospective cases. This means 25+25 cases per clinic or 5+5 cases treated by each surgeon. The anonymized images of the surgeon's last 5 patients (retrospective part) and the pseudonymized images of the next 5 patients meeting the eligibility criteria (prospective part) will be assessed. Patients are eligible if they are at least 18 years old, have an AO 31-A1, A2 or A3 fracture and were treated with either a Proximal Femoral nail Antirotation (PFNA), a PFNA- II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN).

Individually, the 5 surgeons per clinic review the 25 post-implant intraoperative lateral images filed for 5 retrospective cases using a set of predefined criteria.

After this first assessment of retrospective cases, the group watches a video and a poster and has one hour of time to discuss it. The group reviews the 25 cases from the pre-education step again within a period of maximum 5 days. The data are analyzed at AO Clinical Investigation and Documentation (AOCID) and provided to the surgeons for data review meeting where they agree on areas for improvement and set target goals for the prospective series. For the whole period of the second assessment and the prospective series, the poster is placed in the area of the operating room.

After patient information/consent, eligible patients are included into the prospective part of the study and treated with either an intramedullary nail or a DHS. During the surgery, the surgeons use the newly achieved knowledge to record images.

In the next step, the 5 surgeons per clinic review individually 25 post-implant intraoperative lateral images of 5 prospective cases using the same set of predefined criteria. The data are analyzed at AOCID and review by the Imaging Working Group of AO Education.

The data are not transferred between the clinics. The main outcomes will be assessed based on the "Questionnaire for the assessment of the lateral intraoperative view of the proximal femur".

This questionnaire consists of seven questions, on image quality (Q1 and Q2; part A) and on quality of reduction and surgery (Q3 - Q7; part B). Q1 and Q2 allow only "yes/no" answers, with an option to comment on the answer "no". Q3 to Q5 are www.aocid.org

40

based on anatomical assessments and Q6 and Q7 ask for evaluation of the surgery.

There is a "not assessable" answer option for all questions of part B.

Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Patients are eligible if they are at least 18 years old, have an AO 31-A1, A2 or A3 fracture and were treated with either a Proximal Femoral nail Antirotation (PFNA), a PFNA- II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN).

Criteria Inclusion Criteria: •

Age 18 years and older

•

Diagnosis of a pertrochanteric femoral fracture (AO 31-A1, A2, A3)

•

Surgical treatment with either a Proximal Femoral Nail Antirotation (PFNA), a PFNAII, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN) For the prospective part of the study: Informed consent obtained, i.e.:

•

Ability to understand the content of the patient information/Informed Consent Form

•

Willingness to allow the use of health-related data (images) according to the Clinical Investigation Plan (CIP)

•

Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria:

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For the prospective part of the study: - Mentally handicapped patients or patients with dementia that are not able to understand the content patient information/Informed Consent Form

Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT02272972.

Contacts Contact: Sabine M Goldhahn, MD

+4161861101 1

sabine.goldhahn@aofoundation. org

Locations United States, Missouri University of Missouri Hospital and Clinics

Not yet recruiting

Columbia, Missouri, United States, 65212 Contact: Brett D Crist, MD 573-882-6562 cristb@health.missouri.edu Principal Investigator: Brett D Crist, MD Austria Hospital of the Medical University Graz

Not yet recruiting

Graz, Austria, 8036 Contact: Franz-Josef Seibert, Prof., MD +4331638582155 franz.seibert@medunigraz.at Principal Investigator: Franz-Josef Seibert, Prof., MD Slovenia University Medical Centre Ljubljana

Not yet recruiting

Ljubljana, Slovenia, 1000 www.aocid.org

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Contact: Matevz Tomazevic, MD +38659019851 matevzt@gmail.com Principal Investigator: Matevz Tomazevic, MD Switzerland Cantonal Hospital Winterthur

Not yet recruiting

Winterthur, ZH, Switzerland, 8401 Contact: Christoph Meier, MD +4152 2662412 christoph.meier@ksw.ch Principal Investigator: Christoph Meier, MD Municipal Hospital Triemli

Not yet recruiting

Zurich, ZH, Switzerland, 8063 Contact: Andreas Platz, Prof., MD +41 44 466 22 05 andreas.platz@triemli.zuerich.ch Principal Investigator: Andreas Platz, Prof., MD

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator:

Daniel Rikli, MD University Hospital, Basel, Switzerland

More Information Publications: Heetveld MJ, Raaymakers EL, van Walsum AD, Barei DP, Steller EP. Observer assessment of femoral neck radiographs after reduction and dynamic hip screw fixation. Arch Orthop Trauma Surg. 2005 Apr;125(3):160-5. Epub 2005 Mar 2.

Karanicolas PJ, Bhandari M, Walter SD, Heels-Ansdell D, Sanders D, Schemitsch E, Guyatt GH. Interobserver reliability of classification systems to rate the quality of femoral neck fracture reduction. J Orthop Trauma. 2009 Jul;23(6):408-12. doi: www.aocid.org

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10.1097/BOT.0b013e31815ea017.

Rushton MN, Rushton VE, Worthington HV. The value of a quality improvement programme for panoramic radiography: a cluster randomised controlled trial. J Dent.

2013 Apr;41(4):328-35. doi: 10.1016/j.jdent.2012.12.009. Epub 2013 Jan 18.

Zisblatt L, Kues JR, Davis N, Willis CE. The long-term impact of a performance improvement continuing medical education intervention on osteoporosis screening. J Contin Educ Health Prof. 2013 Fall;33(4):206-14. doi: 10.1002/chp.21200.

Cannon CP, Hoekstra JW, Larson DM, Karcher RB, Mencia WA, Berry CA, Stowell SA. A report of quality improvement in the care of patients with acute coronary syndromes. Crit Pathw Cardiol. 2011 Mar;10(1):29-34. doi: 10.1097/HPC.0b013e318204eb8b.

Krettek C, Miclau T, Gr端n O, Schandelmaier P, Tscherne H. Intraoperative control of axes, rotation and length in femoral and tibial fractures. Technical note. Injury.

1998;29 Suppl 3:C29-39.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02272972 Other Study ID Numbers:

PI program II

Study First Received:

October 10, 2014

Last Updated:

October 21, 2014

Health Authority:

Austria: Ethikkommission Slovenia: Ethics Committee Switzerland: Ethikkommission United States: Institutional Review Board

Keywords provided by AO Clinical Investigation and Documentation: "fluoroscopy"[MeSH], "education, medical"[MeSH]

Additional relevant MeSH terms: Femoral Fractures Fractures, Bone

Hip Injuries Leg Injuries www.aocid.org

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Hip Fractures

Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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Treatment of Medial Compartmental Osteoarthritis Grade 1-4 (KellgrenLawrence) or Osteonecrosis With TomoFix™ Small or Conservatively This study is currently recruiting participants. (see Contacts and Locations) Verified July 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Collaborator: Synthes Inc. Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01048710 First received: January 13, 2010 Last updated: July 30, 2014 Last verified: July 2014

Purpose The primary objective of this prospective multicenter study is to assess whether the functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated with open wedge high tibial osteotomy (HTO) using the TomoFix™ Small is better than the functional outcome after conservative treatment.

Condition Osteoarthritis, Knee Osteonecrosis

Study Type:

Observational

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Study Design:

Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM: MedlinePlus related topics: Knee Injuries and Disorders Osteoarthritis Osteonecrosis U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures: •

Patient-evaluated function of the knee and quality of life, a. assessed with the Oxford12-item knee score b. assessed with the WOMAC (as calculated from the KOOS) [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]

•

Clinician-evaluated function of the knee, assessed with the Japanese Orthopaedic Association (JOA) score [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]

•

Health-related quality of life assessed by the generic Short Form-36 (SF-36) instrument [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]

•

Range of motion (ROM) [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]

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•

Local and general pain, assessed with the Visual Analogue Scale (VAS) [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]

•

Possibility and duration of the Japanese sitting style [ Time Frame: 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]

•

Surgery details, Postoperative treatment, Postoperative rehabilitation, Utilization [ Time Frame: postoperative period ] [ Designated as safety issue: No ]

•

Evaluation of degenerated and regenerated cartilage (arthroscopic findings assessed according to ICRS and Outerbridge / Koshino) [ Time Frame: intraoperative and after 2 years ] [ Designated as safety issue: No ]

•

Radiological parameters (e.g. union, delayed union, Kellgren-Lawrence classification, joint space narrowing, tibial slope, tibia vara, patella height according to BlackburnePeel, modified Insall-Salvati ratio, subluxation of patella) [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ]

•

Complications and mortality [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, and 5 years ] [ Designated as safety issue: No ] Estimated Enrollment:

148

Study Start Date:

July 2009

Estimated Study Completion Date:

February 2016

Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure) Groups/Cohorts Tomofix_small

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Conservative treatment

Eligibility Ages Eligible for Study:

40 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Patients with Indication for open wedge HTO with the TomoFix™ Small presenting in the orthopaedic department of the participating hospitals

Criteria Inclusion Criteria: •

40 years of age and older

•

Patients with OA Grade 1-4 (Kellgren-Lawrence) or osteonecrosis (ON) Stage 2-4 (according to the Koshino classification)

•

Indication for open wedge HTO with the TomoFix™ Small

•

No ligamental laxity

•

Signed written informed consent (by the subjects or legal guardian) and agreement to attend all planned follow-ups

•

Willing and able to comply with the postoperative management program

•

Able to understand and read country national language at an elementary level

Exclusion Criteria: •

Femoro-tibial angle (FTA) > 185o (standing view x-ray)

•

Flexion contracture > 15o

•

Total knee replacement or unicompartmental knee on the contralateral side

•

Infections located between the middle of the femur and the ankle

•

Systemic bacterial infections

•

Severe osteoarthritis or surgery of the hip joint

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•

Smoking of more than 20 cigarettes per day

•

Immunodeficiency or compromised host

•

Patients who have participated in any other device or drug related clinical trial within the previous month

•

ACL/PCL reconstruction of the same knee

•

Severe osteoarthritis of the ipsilateral ankle joint For conservative group only:

•

HTO on the contralateral side

•

Major surgery on both knees (minor surgery as arthroscopic meniscectomy and synovectomy is allowed) Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01048710.

Contacts Contact: Takeshi Sawaguchi, MD

+81 (0) 76 422 1112

sawaguch@mxq.mesh.ne.j p

Locations Japan Toyama Municipal Hospital

Recruiting

Toyama-city, Japan, 939-8511

Sponsors and Collaborators AO Clinical Investigation and Documentation Synthes Inc.

More Information Publications: Takeuchi R, Aratake M, Bito H, Saito I, Kumagai K, Hayashi R, Sasaki Y, Akamatsu www.aocid.org

50

Y, Ishikawa H, Amakado E, Aota Y, Saito T. Clinical results and radiographical evaluation of opening wedge high tibial osteotomy for spontaneous osteonecrosis of the knee. Knee Surg Sports Traumatol Arthrosc. 2009 Apr;17(4):361-8. doi: 10.1007/s00167-008-0698-4. Epub 2009 Jan 23.

Takeuchi R, Ishikawa H, Aratake M, Bito H, Saito I, Kumagai K, Akamatsu Y, Saito T. Medial opening wedge high tibial osteotomy with early full weight bearing.

Arthroscopy. 2009 Jan;25(1):46-53. doi: 10.1016/j.arthro.2008.08.015. Epub 2008 Oct 10.

Takeuchi R, Saito T, Koshino T. Clinical results of a valgus high tibial osteotomy for the treatment of osteoarthritis of the knee and the ipsilateral ankle. Knee. 2008 Jun;15(3):196-200. doi: 10.1016/j.knee.2008.02.002. Epub 2008 Mar 25.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01048710 Other Study ID Numbers:

Tomofix_small

Study First Received:

January 13, 2010

Last Updated:

July 30, 2014

Health Authority:

Japan: Ministry of Health, Labor and Welfare

Keywords provided by AO Clinical Investigation and Documentation: Knee osteoarthritis knee osteonecrosis osteotomy

Additional relevant MeSH terms: Osteoarthritis Osteoarthritis, Knee Osteonecrosis Arthritis Bone Diseases

Joint Diseases Musculoskeletal Diseases Necrosis Pathologic Processes Rheumatic Diseases

www.aocid.org

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ClinicalTrials.gov processed this record on February 12, 2015.

www.aocid.org

52

Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System (Epoca H vs T) This study is currently recruiting participants. (see Contacts and Locations) Verified March 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Collaborator: Synthes GmbH Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01288066 First received: January 31, 2011 Last updated: March 25, 2014 Last verified: March 2014

Purpose The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power. In this study, patients are randomly allocated to a treatment with a hemi- or total shoulder arthroplasty using implants of the Epoca system. The primary objective is the comparison of pain and function between the treatment groups after 5 years using the Constant score.

Condition Osteoarthritis

Intervention

Procedure: Hemiarthroplasty Procedure: Total arthroplasty

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Study Type:

Interventional

Study Design:

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Official Title:

A Randomized Multicenter Study Comparing the Effectiveness of Hemi- Versus Total Shoulder Arthroplasty in Patients With a Degenerative Joint Disease

Resource links provided by NLM: MedlinePlus related topics: Joint Disorders Osteoarthritis U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

The Constant score assessment of shoulder function and pain [ Time Frame: Baseline to 5 years postsurgery] [ Designated as safety issue: No ] The primary outcome measure is the difference between the Constant score assessment of shoulder function and pain at baseline and 5 years after surgery. This difference is assessed for each individual patient.

Secondary Outcome Measures:

•

Constant score [ Time Frame: 6 months, 1 year, 3 years ] [ Designated as safety issue: No ]

•

Shoulder Pain and Disability Index (SPADI) [ Time Frame: 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]

•

Duration of surgery [ Time Frame: 1-2 days ] [ Designated as safety issue: No ]

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•

Numbers of adverse events [ Time Frame: Baseline to 5 years follow-up ] [ Designated as safety issue: No ]

•

Survivorship of implants [ Time Frame: Baseline to 5 years follow-up ] [ Designated as safety issue: No ]

•

Quality of life [ Time Frame: Baseline, 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ] Quality of life is assessed using the Euroqol - 5 Dimensions (EQ-5D) questionnaire

Estimated Enrollment:

94

Study Start Date:

September 2011

Estimated Study Completion Date:

February 2020

Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure) Arms

Assigned Interventions

Hemiarthroplasty

Procedure: Hemiarthroplasty

Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system.

Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.

Total arthroplasty

Procedure: Total arthroplasty

Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system.

Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.

Detailed Description: www.aocid.org

55

Shoulder arthroplasty is accepted as the treatment of choice for improved function with minimum pain in well-selected patients. A persistent discussion remains as to whether replacement of the glenoid (ie, total arthroplasty) should be performed.

Possible advantages of glenoid replacement include decreased pain compared to hemiarthroplasty with a metal-on-bone articulation, increased stability due to the conforming glenoid component, and lateralization of the joint center providing improved range of motion and abduction strength. Potential complications of glenoid replacement are implant loosening and loss of glenoid bone stock.

If a hemiarthroplasty is performed, glenoid replacement and related complications are avoided. In addition, hemiarthroplasty requires less surgical time and is less expensive than total shoulder arthroplasty.

To date, there is no evidence to answer the clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease. In this study, both the stemmed Epoca humeral component (Epoca Stem) and the Epoca Resurfacing Head (Epoca RH) are included. While the stemmed prosthesis was developed both for nonreconstructable fractures and omarthroses, the humeral resurfacing head implant was designed specifically for use in degenerative diseases of the shoulder joint.

This randomized multicenter study aims to compare the efficacy of hemi versus total shoulder arthroplasty using Epoca RH or Epoca Stem in patients with degenerative joint diseases. The primary aim of the present study is to demonstrate that the Constant score assessing shoulder function and pain is higher in the patient group treated with total arthroplasty compared to the hemiarthroplasty group after 5 years.

The secondary aims of the study are to assess differences in the Shoulder Pain and Disability Index (SPADI), duration of surgery, rates of local and general adverse events and relationship to the device or treatment under investigation, survivorship of the implants, and quality of life after 6 months, 1, 3 and 5 years between the treatment groups.

Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria Inclusion Criteria: www.aocid.org

56

•

Age 18 years and older

•

Primary or secondary omarthrosis (eg, rheumatoid arthritis, avascular head necrosis)

•

Glenoid morphologic type A1, A2 or B1 according to Walch

•

Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation

•

Written informed consent

Exclusion Criteria: Preoperative: •

Posttraumatic omarthrosis

•

Biconcave aspect of glenoid (Walch type B2)

•

Retroversion of glenoid more than 25° (Walch type C)

•

"Epoca Reko" prosthesis

•

Humerus fractures

•

Patients with a severe systemic disease: class III-IV according to the American Society of Anaesthesiologists physical status classification (ASA)

•

Substance abuse that would preclude reliable assessment

•

Pregnancy

•

Prisoners

•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study Intraoperative:

•

Full thickness tear of rotator cuff

•

Indication for hemiarthroplasty only

•

Indication for total arthroplasty only

•

Intraoperative decision to use implants other than Epoca Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01288066.

Contacts Contact: Denise Schmid

0041 44 200 24 77

denise.schmid@aofoundation.org

Locations www.aocid.org

57

Austria Recruitin g

Medizinische Universität Innsbruck, Austria, 6020 Contact: Michael Blauth, Prof Principal Investigator: Michael Blauth, Prof Germany

Recruitin g

BG Unfallklinik Frankfurt Frankfurt, Germany, 60389 Contact: Frederic Welsch, M.D Principal Investigator: Frederic Welsch, M.D

Recruitin g

Universitätsklinikum Freiburg Freiburg, Germany Principal Investigator: Norbert Suedkamp, MD Klinikum Region Hannover GmbH, Klinikum Agnes-Karll Laatzen

Recruitin g

Laatzen, Germany, 30880 Contact: Thomas Berndt, M.D Principal Investigator: Thomas Berndt, M.D Sweden

Universitetssjukhuset Ortopedicentrum i Östergötland

Recruitin g

Linköping, Sweden, 58185

www.aocid.org

58

Contact: Lars Adolfsson, M.D Principal Investigator: Lars Adolfsson, M.D

Sponsors and Collaborators AO Clinical Investigation and Documentation Synthes GmbH

Investigators Principal Investigator:

Norbert Suedkamp, MD

Universit채tsklinikum Freiburg, Deutschland

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01288066 Other Study ID Numbers:

Epoca Hemi vs. Total 2011

Study First Received:

January 31, 2011

Last Updated:

March 25, 2014

Health Authority:

Germany: Ethics Commission

Keywords provided by AO Clinical Investigation and Documentation: Shoulder Resurfacing Total arthroplasty Glenoid Hemiarthroplasty Constant score

Additional relevant MeSH terms: Osteoarthritis www.aocid.org

59

Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

ClinicalTrials.gov processed this record on February 12, 2015.

www.aocid.org

60

CPP Bone Infection Registry (CPP Infection) This study is currently recruiting participants. (see Contacts and Locations) Verified January 2015 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01677000 First received: August 29, 2012 Last updated: January 14, 2015 Last verified: January 2015

Purpose Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from ≼20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry. The registry will include: 1. baseline patient attributes; 2. surgical approach, implants and technology; 3. hospital course; 4. surgeon and institutional characteristics; 5. longitudinal patient outcome, 6. post-procedure complications and revisions, 7. serum/tissue/drainage samples.

www.aocid.org

61

Condition Bone Infection Staphylococcus Aureus

Study Type:

Observational

Study Design:

Observational Model: Case-Only Time Perspective: Prospective

Official Title:

Clinical Priority Program: Bone Infection; Use of a Registry on Infection to Improve Patient Outcomes and Research Efforts

Resource links provided by NLM: Genetic and Rare Diseases Information Center resources: Osteomyelitis U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Details on occurence and treatment of bone infection [ Time Frame: 1 December 2012 ] [ Designated as safety issue: No ] Secondary Outcome Measures:

•

Surgical approach, implants and technology [ Time Frame: 01 December 2012 ] [ Designated as safety issue: No ]

•

Patient outcome [ Time Frame: 01 December 2012 ] [ Designated as safety issue: No ]

•

Post-procedure complications and revisions [ Time Frame: 01 December 2012 ] [ Designated as safety issue: No ]

www.aocid.org

62

Biospecimen Retention: Samples With DNA blood samples nasal and wound specimen

Estimated Enrollment:

400

Study Start Date:

June 2012

Estimated Study Completion Date:

June 2017

Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure) Detailed Description: Establish an international registry with AOCID of over 400 patients with deep infections involving the bone and/or joint from ≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Creation of an AOCID Registry for musculoskeletal infection cases will permit better analysis of the causes, contributing factors including patient immune responses, treatments and clinical outcomes of musculoskeletal infections.

•

Establish a practice network that includes ≥ 20 geographically distributed centers.

These busy practices will be treating patients with varied geographic status to assure balanced representation of diverse patients and practices.

•

Establish a Data Coordinating Core team with AOCID using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry.

The registry will include: •

baseline patient attributes

•

surgical approach, implants and technology

•

hospital course

•

surgeon and institutional characteristics

•

longitudinal patient outcome

•

post-procedure complications and revisions

•

serum/tissue/drainage samples

www.aocid.org

63

o

Establish a Statistical Support team with AOCID to implement cutting-edge statistical techniques including the use of hierarchical generalized linear latent and mixed effects models to address the complex structure and longitudinal nature of registry data. Multivariable predictive models for outcome(s) of infection will be developed.

o

Establish an Outcomes Measurement Team with AOCID and Investigators from the CPP team to advance the science of infection-specific and global patient-reported outcomes to support efficient data collection of web-based, longitudinal data in this registry and future comparative effectiveness research.

o

Develop new assessment tools and conduct research useful to clinical practice.

Establish consensus on the definition of treatment failure- characterized as lack of clinically meaningful improvement in infection, pain or physical function following treatment, validate, and refine prediction algorithms for patients at risk for failure.

Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population patients with diagnosis of Staphylococcus aureus bone infection

Criteria Inclusion Criteria: •

Patients aged 18 years or older

•

Confirmed* oxacillin-/methicillin-sensitive Staphylococcus aureus (OSSA/ MSSA) or methicillin resistant Staphylococcus aureus (MRSA) infection involving a long bone (ie, femur, tibia, fibula, humerus, radius, ulna, and clavicle) with one (or a combination) of the following:

o

Osteomyelitis

o

Fracture fixation hardware /prosthetic joint infection

o

Infection around an arthroplasty

•

Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation www.aocid.org

64

•

Signed written informed consent * Confirmed either by positive culture from baseline examination or by positive culture from a prior examination of the same surgical site and definitely ongoing infection with Staphylococcus aureus according to the treating surgeon

Exclusion Criteria: •

Patients who cannot give informed consent

•

Patients who cannot attend the follow up visits

•

Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

•

Prisoner Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01677000.

Contacts

Contact: Patrick Hiltpold

+41 44 200 24 66

patrick.hiltpold@aofoundation.org

Contact: Stephen L Kates, MD

+1 585 34 10 485

stephen_kates@urmc.rochester. edu

Locations United States, Missouri University of Missouri Health Care

Recruiting

Columbia, Missouri, United States, 65212 United States, New York Unity Hospital

Recruiting

Rochester, New York, United States, 14626

www.aocid.org

65

University of Rochester

Recruiting

Rochester, New York, United States, 14642 Contact: Stephen L Kates, MD 585-341-0485 stephen_kates@urmc.rochester.edu United States, Pennsylvania Geisinger Health System

Recruiting

Danville, Pennsylvania, United States, 17822 Argentina Hospital Italiano de Buenos Aires

Recruiting

Buenos Aires, Argentina, C1181ACH Austria Medizinische Universitaetsklinik Innsbruck

Recruiting

Innsbruck, Austria, 6020 Belgium Universitair Ziekenhuis Leuven

Not yet recruiting

Leuven, Belgium, 3000 Canada, Alberta Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, AB T2N 2T9 China, Chongqing Southwestern Hospital Chongqing

Recruiting

Chongqing, Chongqing, China, 400038

www.aocid.org

66

China, Guizhou Affiliated Hospital of Zunyi Medical College

Recruiting

Zunyi, Guizhou, China, 56003 China Zhejiang Provincial People's Hospital

Recruiting

Hangzhou, China, 310014 Queen Mary Hospital

Recruiting

Hong Kong, China Denmark Aarhus University Hospital

Recruiting

Aarhus, Denmark, 8000 Germany Berufsgenossenschaftliche Unfallklinik Murnau

Recruiting

Murnau, Bavaria, Germany, 82418 Justus-Liebig-Universit채t

Recruiting

Giessen, Germany, 35592 Universitaetsklinikum Regensburg

Recruiting

Regensburg, Germany, 93042 Japan Hokkaido University Graduate School of Medicine

Recruiting

Sapporo, Hokkaido, Japan, 060-8638 Hamawaki Orthopaedic Hospital www.aocid.org

Recruiting 67

Hiroshima, Japan, 730-0051 Switzerland Universit채tsspital Basel

Recruiting

Basel, Basel Stadt, Switzerland, 4031

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator:

Steven L Kates, MD University of Rochester

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01677000 Other Study ID Numbers:

CPP Infection Registry

Study First Received:

August 29, 2012

Last Updated:

January 14, 2015

Health Authority:

United States: Institutional Review Board Argentina: Ethics Committee Austria: Ethikkommission Canada: Ethics Review Committee China: Ethics Committee Denmark: Ethics Committee Germany: Ethics Commission Japan: Institutional Review Board Switzerland: Ethikkommission www.aocid.org

68

Keywords provided by AO Clinical Investigation and Documentation: bone infection staphylococcus aureus registry

Additional relevant MeSH terms: Communicable Diseases Infection Osteomyelitis

Bone Diseases Bone Diseases, Infectious Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 12, 2015.

www.aocid.org

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Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) (FR TFNA) This study is not yet open for participant recruitment. (see Contacts and Locations) Verified November 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02305121 First received: November 22, 2014 Last updated: January 16, 2015 Last verified: November 2014

Purpose The aim of this project is the prospective data collection of a new device used for trochanteric fractures of the femur. It should be answered how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiological in terms of intra- and postoperative complications.

Condition Pertrochanteric Fractures of Femur Intertrochanteric Fractures of the Femur

Study Type:

Observational

Study Design:

Observational Model: Case-Only www.aocid.org

Intervention Device: TFNA

70

Time Perspective: Prospective Official Title:

A Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) - TFNA System in Patients With Proximal Inter-, Per- or Subtrochanteric Fractures

Resource links provided by NLM: MedlinePlus related topics: Fractures Leg Injuries and Disorders U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

The rate of mechanical and surgical complications defined as the number of [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

o

cut out and cut through

o

secondary displacement of parts of the implant

o

breakage of the implant

o

iatrogenic fractures

o

surgical revisions

o

acute deep infection Secondary Outcome Measures:

•

OR time [ Time Frame: Intraoperative ] [ Designated as safety issue: No ] (in min)

•

Fracture classification Classification [ Time Frame: Baseline ] [ Designated as safety issue: No ] according to AO/OTA Fracture and Dislocation

•

Parker Mobility Score [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

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71

Evaluation of the mobility •

Quality of reduction and implant placement [ Time Frame: up to 3 months ] [ Designated as safety issue: No ] Based on radiographic analysis with focus on the position of the nail tip relative to the femoral canal and the migration of the head neck element

Estimated Enrollment:

50

Study Start Date:

February 2015

Estimated Study Completion Date:

February 2016

Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure) Intervention Details: Device: TFNA All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery Detailed Description: In comparison to previous implants, the TFNA has been improved substantially.

Therefore the purpose of this focused registry is to investigate how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiologically in terms of surgical technique, intraand postoperative complications and short term outcome.

All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery.

Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both www.aocid.org

72

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Patients with per- or intertrochanteric fractures of the femur, fracture of the trochanteric area with diaphyseal extension or combined fractures of the trochanteric area and the femoral shaft.

Criteria Inclusion Criteria: •

Age 18 years and older

•

Pertrochanteric femoral fracture (31-A1 and 31-A2), intertrochanteric fracture (31-A3), fracture of the trochanteric area (31-A1/A2/A3) with diaphyseal extension or combined fracture of the trochanteric area and the femoral shaft (32-A/B/C) treated with the TFNA system according to the technique guide

•

Ability to understand the content of the patient information / informed consent form

•

Willingness and ability to participate in the registry according to the registry plan (RP)

•

Signed and dated IRB/EC-approved written informed consent or assent from a family member

Exclusion Criteria: •

Additional acute fracture

•

Any not medically managed severe systemic disease

•

Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment

•

Pregnancy or women planning to conceive within the registry period

•

Prisoner

•

Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry

•

Intraoperative decision to use implants other than the devices under investigation Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT02305121.

Locations www.aocid.org

73

Austria Medical University Innsbruck

Not yet recruiting

Innsbruck, Austria, 6020 Contact: Michael Blauth, Professor +4351250422821 michael.blauth@imed.ac.at

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator:

Michael Blauth, Professor

Medical University Innsbruck, Department of Trauma Surgery

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02305121 Other Study ID Numbers:

FR TFNA

Study First Received:

November 22, 2014

Last Updated:

January 16, 2015

Health Authority:

Austria: Ethic Commission

Keywords provided by AO Clinical Investigation and Documentation: Trochanteric fracture Antirotation Nail trochanteric area with diaphyseal www.aocid.org

74

Fracture reduction

extension trochanteric area with femoral shaft

Additional relevant MeSH terms: Femoral Fractures Fractures, Bone Hip Fractures

Hip Injuries Leg Injuries Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

www.aocid.org

75

Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment This study is not yet open for participant recruitment. (see Contacts and Locations) Verified July 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01672749 First received: August 22, 2012 Last updated: July 30, 2014 Last verified: July 2014

Purpose The foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine.

Current treatment options require repetitive interventions as the spine and the child grow. This study will compare two techniques of growth modulation: Standard dual growing rods versus the new LuquĂŠ Trolley screws Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer re-operations after 3 years of follow-up (FU) than patients included in the comparison group

Condition Early Onset Scoliosis (EOS)

Intervention Device: Growth guiding construct using TROLLEY system Device: Spine based dual growing rod or rib based VEPTR

www.aocid.org

76

Study Type:

Observational

Study Design:

Observational Model: Cohort Time Perspective: Prospective

Official Title:

Evaluation of a Growth Guiding Construct vs. Standard Dual Growing Rods and VEPTR for the Treatment of Early Onset Scoliosis Patients: A Prospective Multi-center Cohort Study With a Matched Historical Control

Resource links provided by NLM: MedlinePlus related topics: Scoliosis Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Number of re-operations [ Time Frame: 3 years FU ] [ Designated as safety issue: No ] Number of re-operations of the spine per patient in both groups after 3 years of FU Secondary Outcome Measures:

•

Sitting height [ Time Frame: 10 years ] [ Designated as safety issue: No ]

•

Standing height [ Time Frame: 10 years ] [ Designated as safety issue: No ]

•

Radiographic measurements [ Time Frame: 10 years ] [ Designated as safety issue: No ]

o

Spine length: upper T1 to lower L5 end plates

o

Chest length: upper T1 to Lower T12

o

Instrumented spine length

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77

•

Curve / deformity type characteristics [ Time Frame: 10 years ] [ Designated as safety issue: No ]

o

Lenke classification

o

New EOS classification

•

Adverse Events related to the procedure and/or device under investigation [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

•

Quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]

o

EOS Questionnaire (EOSQ 24)

o

Pediatric version of EQ-5D (EQ-5D-Y)

•

Pulmonary function: [ Time Frame: 10 years ] [ Designated as safety issue: No ]

o

Forced vital capacity (FVC), actual [L] and predicted [%]

o

Forced expiratory volume in 1 second (FEV1), actual [L] and predicted [%]

o

Total lung capacity (TLC), actual [L] and predicted [%]

o

Use and rate of assisted ventilation

o

Residual volume (RV)

•

Growth potential [ Time Frame: 10 years ] [ Designated as safety issue: No ]

o

Chronological age

o

Bone age (based on radiograph of the hand)

Estimated Enrollment:

51

Study Start Date:

September 2015

Estimated Study Completion Date:

July 2026

Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure) Groups/Cohorts

Assigned Interventions

Spine based dual growing rod or VEPTR

www.aocid.org

Device: Spine based dual growing rod or rib based 78

Patients treated with the TROLLEY system will be compared with patients from the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG) treated with a spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America). For each patient in the TROLLEY group a patient from each of the databases will be selected to be matched based on diagnosis, age, gender, and spine deformity classification.

VEPTR

TROLLEY system

Device: Growth guiding construct using TROLLEY system

Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs). The TROLLEY system is CE marked at the time of the study conduct.

spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)

Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)

Detailed Description: The purpose of this clinical study is to show that the growth guiding construct with DePuy Synthes TROLLEY Gliding Vehicles allows for less re-operations and for ongoing spinal growth across an instrumented immature spine while preventing curve progression in early onset scoliosis patients.

Eligibility Ages Eligible for Study:

5 Years to 10 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population One third of the patients will be recruited in designated investigation sites using the TROLLEY system. For each trolley patient one to two comparative matched pairs will

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be generated from mining the database of the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG).

Criteria Inclusion Criteria: •

Age 5 - 10 years

•

Diagnosis of Early Onset Scoliosis with any of the following etiologies: Idiopathic Congenital Neuromuscular Syndromic Mesenchymal - Significant growth potential defined by any of the following: pre peek growth velocity bone age < 10; open triradiate cartilage

•

An expected significant spinal deformity of more than 80 degrees at skeletal maturity

•

Signed informed consent as legally required (patient, parents, etc.)

•

Willingness and ability of the patient to participate in the clinical investigation including imaging and FU procedures

•

Willingness and ability of the parents to support the patient in his/her study participation

•

Ability of the patient and parents to understand the content of the patient information / informed consent form and participate in the clinical investigation

•

Signed informed consent by patient / parent(s)

Exclusion Criteria: •

Curve magnitude and rigidity: Cobb greater than 100 degrees or bends less than 50 degrees

•

Prior spinal surgery

•

Skeletal maturity

•

Any not medically managed severe systemic disease

•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01672749.

Contacts

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Contact: Denise Schmid

+41 44 200 24 77

Contact: Marina Kueng

+41 81 414 25 05

denise.schmid@aofoundation.org

Locations Canada McGill University Health Science Centre - Montreal Children Hospital

Not yet recruiting

Montreal, Canada, 2300 Principal Investigator: Jean Ouellet, MD, FRCSC Sponsors and Collaborators AO Clinical Investigation and Documentation Investigators Principal Investigator:

Jean Ouellet, MD

McGill University Health Science Centre, Montreal, Canada

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01672749 Other Study ID Numbers:

EOS TROLLEY

Study First Received:

August 22, 2012

Last Updated:

July 30, 2014

Health Authority:

Canada: Ethics Review Committee

Keywords provided by AO Clinical Investigation and Documentation: www.aocid.org

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Scoliosis [MESH] Pediatrics [MESH] Early onset Growth guidance

Growing rod Trolley Dual growing rod technique

Additional relevant MeSH terms: Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

ClinicalTrials.gov processed this record on February 12, 2015.

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A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP) This study is not yet open for participant recruitment. (see Contacts and Locations) Verified March 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02093364 First received: March 18, 2014 Last updated: March 19, 2014 Last verified: March 2014

Purpose The purpose of this focused registry is to evaluate the clinical implications of the RHP position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the RHP with a straight and curved stem.

Condition Elbow Radial Head Prosthesis Implantation Radial Head Prosthesis Radial Head Fracture

Study Type:

Observational [Patient Registry]

Study Design:

Observational Model: Case-Only www.aocid.org

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Time Perspective: Prospective Target Follow-Up Duration: 12 Months Official Title:

A Focused Registry to Document the Use of the Shortor Long-stemmed Radial Head Prosthesis (RHP)

Resource links provided by NLM: MedlinePlus related topics: Fractures U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Evaluation of the functional outcome [Time Frame: 12 Months] [Designated as safety issue: No] Elaborate if there is an association between the implant head and stem position (relative to the elbow articulations), functional outcomes and radiological parameters (radiolucency and arthritis) after 1 year in patients treated with a RHP Secondary Outcome Measures:

•

Evaluation of functional outcome [ Time Frame: 24 months ] [ Designated as safety issue: No ] Elaborate if there is an association between the implant head and stem position (relative to the elbow articulations), functional outcomes and radiological parameters (radiolucency and arthritis) after 2 years

•

Range of motion [ Time Frame: 12 months ] [ Designated as safety issue: No ] To investigate range of motion of the injured limb as compared to the contralateral side

•

Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ] To evaluate if the related adverse events have an effect on quality of life (EQ5D)

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Estimated Enrollment:

60

Study Start Date:

July 2014

Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure) Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Primary care centers

Criteria Inclusion Criteria: •

Age 18 years or older

•

Use of a short-or long-stemmed DePuy Synthes Radial Head Prosthesis due to any of the following indications:

o

Fresh fracture of the radial head which is not amendable to an adequate steosynthesis

o

Post-traumatic deformity or arthroses

o

Failed open reduction internal fixation (ORIF)

o

Failed conservative radial head fracture treatment

•

Informed consent obtained, i.e.:

o

Ability to understand the content of the patient information / Informed Consent Form

o

Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)

o

Signed and dated Ethics Committee (EC) / Institutional Review Board (IRB) approved written informed consent

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Exclusion Criteria: •

Active infection at the affected elbow

•

Any not medically managed severe systemic disease

•

Pregnancy

•

Prisoner

•

Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment Contacts and Locations No Contacts or Locations Provided.

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02093364 Other Study ID Numbers:

FR Radial Head Prosthesis

Study First Received:

March 18, 2014

Last Updated:

March 19, 2014

Health Authority:

United States: Institutional Review Board

Additional relevant MeSH terms: Radius Fractures Arm Injuries Forearm Injuries Fractures, Bone Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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Latin America Hip Fracture Mortality Study (LAMOS) This study is currently recruiting participants. (see Contacts and Locations) Verified March 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01650064 First received: July 6, 2012 Last updated: March 25, 2014 Last verified: March 2014

Purpose The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.

Condition Hip Fractures

Study Type:

Observational

Study Design:

Observational Model: Cohort Time Perspective: Prospective

Official Title:

Latin America Hip Fracture Mortality Study

Resource links provided by NLM:

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MedlinePlus related topics: Fractures Hip Injuries and Disorders U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Death [ Time Frame: after 1 year ] [ Designated as safety issue: No ] Secondary Outcome Measures:

•

Harris Hip Score [ Time Frame: Screening/Preoperative and 90 ± 21 days ] [ Designated as safety issue: No ]

•

Parker Mobility Score [ Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days ] [ Designated as safety issue: No ]

•

Wound healing [ Time Frame: 30±7 days, 60±14 days, and 90± 21 days ] [ Designated as safety issue: No ]

•

Fracture healing [ Time Frame: 60±14 days and 90± 21 days ] [ Designated as safety issue: No ]

•

Anticipated surgical treatment-related adverse events [ Time Frame: Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days ] [ Designated as safety issue: No ]

•

EQ-5D [ Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days ] [ Designated as safety issue: No ] Estimated Enrollment:

300

Study Start Date:

January 2013

Estimated Study Completion Date:

June 2015

Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure) Eligibility Ages Eligible for Study:

60 Years and older

Genders Eligible for Study:

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Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Patients with surgically-treated hip fracture in Latin America

Criteria Inclusion Criteria: •

Adults 60 years and older

•

Diagnosis of an isolated intertrochanteric fracture (AO 31-A) confirmed by radiographic evaluation

•

Primary surgical fracture treatment within 10 days after trauma

•

No prior treatment for the fracture

•

Ability to understand the content of the patient information / informed consent form

•

Willingness and ability to participate in the clinical investigation according to the CIP

•

Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria: •

Polytrauma (ie, multiple injuries, whereof one or the combination of several injuries is life threatening)

•

Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)

•

Active malignancy

•

Class 5 and 6 of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 2)

•

Neurological and/or psychiatric disorders that would preclude reliable assessment (eg, Parkinson's disease, multiple sclerosis, severe depression)

•

Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

•

Prisoner

•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

•

Noncompletion of patient baseline questionnaires

•

Prior implant on the fractured hip

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Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01650064.

Contacts Contact: Shandher Tovar, Dr.med

+51 997 511 008

shandher.tovar@aofoundation. org

Contact: Denise Schmid

+41 44 200 2477

denise.schmid@aofoundation.o rg

Locations Argentina Hospital Italiano de Buenos Aires

Recruiting

Buenos Aires, Argentina Contact: Jorge Barla, MD Principal Investigator: Jorge Barla, MD Brazil Not yet recruiting

Hospital Vila Velha Espirito Santo, Brazil Contact: Jose E Grandi Ribeiro Filho, MD Principal Investigator: Jose E Grandi Ribeiro Filho, MD IOT - Instituto de Ortopedia de Traumatologia de Passo Fundo

Not yet recruiting

Passo Fundo, Brazil Contact: Luiz H Penteado da Silva, MD Principal Investigator: Luiz H Penteado da Silva, MD

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Hospital Municipal Miguel Couto

Not yet recruiting

Rio de Janeiro, Brazil Contact: Vincenzo Giordano, MD Principal Investigator: Vincenzo Giordano, MD

Hospital das Clinicas da UNICAMP

Not yet recruiting

São Paulo, Brazil Contact: William Belangero, MD Principal Investigator: William Belangero, MD Hospital Irmandade da Santa Casa de Misericórdia de São Paulo

Not yet recruiting

São Paulo, Brazil Contact: Ralph W Christian, MD Principal Investigator: Ralph W Christian, MD Not yet recruiting

Hospital São Paulo São Paulo, Brazil Contact: Helio J Alvachian Fernandes, MD Principal Investigator: Helio J Alvachian Fernandes, MD

Not yet recruiting

Universidad de São Paulo São Paulo, Brazil Contact: Kodi E Kojima, MD Principal Investigator: Kodi E Kojima, MD Chile

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Hospital Clínico Pontificia Universidad Católica de Chile

Not yet recruiting

Santiago, Chile Contact: Daniel A Schweitzer Fernández, MD Principal Investigator: Daniel A Schweitzer Fernández, MD

Hospital del Trabajador de Santiago

Not yet recruiting

Santiago, Chile Contact: Alejandro D Zylberberg Serman, MD Principal Investigator: Alejandro D Zylberberg Serman, MD Colombia Not yet recruiting

Hospital Infantil de San José Bogotá, Colombia Contact: Carlos M Olarte Salazar, MD Principal Investigator: Carlos M Olarte Salazar, MD Costa Rica

Not yet recruiting

Hospital San Vicente de Paúl San José, Costa Rica Contact: Kenneth Barquero Blackshaw, MD Principal Investigator: Kenneth Barquero Blackshaw, MD Ecuador

Hospital Teodoro Maldonado Carbo

www.aocid.org

Not yet recruiting

92

Guayaquil, Ecuador Contact: Miguel A Mite Vivar, MD Principal Investigator: Miguel A Mite Vivar, MD Mexico

Hospital de Traumatología y Ortopedia "Lomas Verdes"

Not yet recruiting

Ciudad de México, Mexico Contact: Sergio A Oliva Ramirez, MD Principal Investigator: Sergio A Oliva Ramirez, MD

Hospital de Traumatología y Ortopedia UMAE #21

Not yet recruiting

Monterrey, Mexico Contact: José R Mendoza de la Cruz, MD Principal Investigator: José R Mendoza de la Cruz, MD Uruguay Asociación Española Primera de Socorros Mutuos

Recruiting

Montevideo, Uruguay Contact: Daniel H Rienzi Bergalli, MD Principal Investigator: Daniel H Rienzi Bergalli, MD

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator

Wiliam Belangero,

Department of Orthopaedics and Traumatology, www.aocid.org

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:

Dr.med

Hospital das Clinicas da UNICAMP, Brazil

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01650064 Other Study ID Numbers:

LAMOS

Study First Received:

July 6, 2012

Last Updated:

March 25, 2014

Health Authority:

Brazil: Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation: Hip fracture Mortality

Additional relevant MeSH terms: Fractures, Bone Hip Fractures Femoral Fractures

Hip Injuries Leg Injuries Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program This study is not yet open for participant recruitment. (see Contacts and Locations) Verified November 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02297581 First received: November 17, 2014 Last updated: November 28, 2014 Last verified: November 2014

Purpose The study will assess patients with at least one major AE related to treatment / hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the usual care group.

Condition Hip Fractures

Study Type:

Observational

Study Design:

Observational Model: Cohort Time Perspective: Prospective

Official Title:

A Prospective Multicenter Cohort Study to Evaluate the Benefit of the Geriatric Fracture Center (GFC) Concept

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Resource links provided by NLM: MedlinePlus related topics: Fractures Hip Injuries and Disorders U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Major Adverse Events related to treatment / residential status / immobilization [ Time Frame: From surgery up to 1 year follow-up ] [ Designated as safety issue: No ] Major AEs related to treatment / residential status / immobilization:

o

Delirium

o

Congestive heart failure

o

Pneumonia

o

Deep venous thrombosis

o

Pulmonary embolism

o

Pressure ulcers

o

Myocardial infarction Secondary Outcome Measures:

•

Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization [ Time Frame: From surgery up to 1 year follow-up ] [ Designated as safety issue: No ]

•

Activities of daily living [ Time Frame: Baseline, 12 weeks and 1 year postoperative ] [ Designated as safety issue: No ] Modified Barthel index pre-injury, at 12 weeks and 12 months

•

Number of re-admissions to an acute hospital [ Time Frame: From surgery up to 1 year follow-up ] [ Designated as safety issue: No ]

•

Timed up and go test (TUG) [ Time Frame: 12 weeks and 1 year follow-up ] [ Designated as safety issue: No ]

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•

Parker Mobility Score [ Time Frame: Baseline, 12 weeks and 1 year follow-up ] [ Designated as safety issue: No ] Parker Mobility Score pre-injury, at 12 weeks and 12 months

•

Mortality [ Time Frame: From surgery up to 1 year follow-up ] [ Designated as safety issue: No ]

•

Quality of Life [ Time Frame: 12 weeks and 1 year postoperative ] [ Designated as safety issue: No ] Quality of life using the EuroQoL questionnaire (EQ-5D)

•

Pain [ Time Frame: From surgery up to1 year follow-up ] [ Designated as safety issue: No ] Pain using the numeric rating scale

•

Direct and indirect costs [ Time Frame: Baseline up to 1 year follow-up ] [ Designated as safety issue: No ] All direct and indirect costs will be documented for a cost-effectiveness analysis (medication, treatment, physiotherapy, postoperative care etc)

•

Time from admission to start of pain medication [ Time Frame: Baseline (admission to surgery), about 1-2 days ] [ Designated as safety issue: No ]

•

Time from admission to start of fluid management [ Time Frame: Baseline (admission to surgery), about 1-2 days ] [ Designated as safety issue: No ]

•

Time from admission to surgery [ Time Frame: Baseline (admission to surgery), about 1-2 days ] [ Designated as safety issue: No ]

•

Time from surgery to discharge 1 and 2 [ Time Frame: Baseline (admission to discharge), about 1-2 weeks ] [ Designated as safety issue: No ] Discharge 1 is defined as discharge from orthopaedic / trauma department Discharge 2 is defined as the timepoint when the patient is discharged to their definite residential status, i.e. residential status where no further change in residential status is planned . Discharge 1 and 2 may occur on the same date.

•

Residential status [ Time Frame: Baseline up to 1 year follow-up ] [ Designated as safety issue: No ] Pre-injury, at discharge 1 and 2, at 12 weeks and 12 months

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•

Falls [ Time Frame: From surgery up to 1 year follow-up ] [ Designated as safety issue: No ] Numbers of falls

•

Medication [ Time Frame: Baseline up to 1 year follow-up ] [ Designated as safety issue: No ] Number of different types of medication at admission, discharge 1, 12 weeks, 12 months and information whether analgesics, osteoporosis and other medications are administered at all study visit time points

•

Number of patients receiving adequate secondary fracture prevention [ Time Frame: Baseline up to 1 year follow-up ] [ Designated as safety issue: No ]

•

Number of patients for which the nutrition status was evaluated / adapted [ Time Frame: Baseline (admission to discharge), about 1-2 days ] [ Designated as safety issue: No ]

•

Occurrence of a contralateral hip fracture [ Time Frame: Retrospective assessment of pre-injury status up to 1 year follow-up ] [ Designated as safety issue: No ] Estimated Enrollment:

266

Study Start Date:

February 2015

Estimated Study Completion Date:

September 2017

Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure) Groups/Cohorts GFC: Geriatric Fracture Center Patient treatment in a geriatric fracture center A GFC is defined as follows: General geriatrician or ortho-geriatrician available in trauma/orthopaedic department Geriatrician sees the patient prior to surgery (except if the patient is admitted over night or during weekends) Local medical guidelines, consented by orthopedic surgeons and geriatrician

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Pre-defined order set for assessing laboratory values Pre-defined patient pathway to guarantee a fast track in the emergency room Daily communication among involved specialists Postoperative phase up to discharge from orthopaedic / trauma department (i.e.

Discharge 1): Daily patient visit by geriatrician Daily patient visit by orthopedic surgeon in combination with nurse Daily therapy by physiotherapists, except for weekends Access to social workers, if required UCC: Usual Care Center Patient treatment in an usual care center A UCC is defined as follows: No geriatrician available in trauma/orthopaedic department No pre-operative visit by a geriatrician as a standard No pre-defined medical guidelines for geriatric fracture patients Postoperative phase up to discharge from orthopaedic / trauma department (i.e.

Discharge 1): No daily patient visits by a geriatrician as a standard

Detailed Description: Patients aged â&#x2030;Ľ 70 years or older with an osteoporotic hip fracture treated with an osteosynthesis or endoprosthesis will be included in this study.

The primary objective of the study is to assess the difference in the numbers of predefined major adverse events (AE) which are related to the treatment, hospitalization and/or immobilization between patients who were treated in a geriatric fracture center or in a usual care center.

As a secondary objective, health economic implications and cost-effectiveness comparison analyses will be performed.

In order to be able to analyze data based on the geographic regions as well as globally, in each participating country, both a Geriatric Fracture Center (GFC) and a Usual Care Center (UCC) will be included.

Eligibility www.aocid.org

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Ages Eligible for Study:

70 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Primary care clinic (Usual Care clinic) Geriatric center

Criteria Preoperative Inclusion Criteria: •

Age ≥ 70 years

•

Geriatric patients with hip fractures Treated either with Osteosynthesis or Endoprosthesis

•

Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form

•

Signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent

Preoperative Exclusion Criteria: •

Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

•

Prisoner

•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT02297581.

Locations United States, Maryland Johns Hopkins Bayview Medical Center

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Not yet recruiting 100

Baltimore, Maryland, United States, 21224 Contact: Erik Hasenboehler, MD 410-550-4189 ehasenb1@jhmi.edu Principal Investigator: Erik Hasenboehler, MD United States, Virginia Naval Medical Center Portsmouth

Not yet recruiting

Portsmouth, Virginia, United States, 23708 Contact: Christopher Smith, MD 757-687-9859 chriss199@yahoo.com Principal Investigator: Christopher Smith, MD Austria Medical University of Innsbruck

Not yet recruiting

Innsbruck, Austria, 6020 Contact: Michael Blauth, Professor +43 (0) 512 504 22821 michael.blauth@i-med.ac.at Principal Investigator: Michael Blauth, Professor AKH Linz

Not yet recruiting

Linz, Austria, 4020 Contact: Sebastian Zohner, MD 004373278063411 sebastian.zohner@akh.linz.at Principal Investigator: Sebastian Zohner, MD Netherlands Ziekenhuisgroep Twente

Not yet recruiting

Almelo, Netherlands, 7609 SZ Contact: Han Hegemann, Phd MD +31 (0) 546 693 991 h.hegeman@zgt.nl Principal Investigator: Ellis Folbert, MD

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Maastricht University Medical Center

Not yet recruiting

Maastricht, Netherlands, 6202 AZ Contact: Martijn Poeze, MD 00314338756 m.poeze@mumc.nl Principal Investigator: Martijn Poeze, MD Singapore General Hospital Singapore

Not yet recruiting

Singapore, Singapore, 169608 Contact: Merng Koon Wong, Prof. 006563214045 wong.merng.koon@sgh.com.sg Principal Investigator: Merng Koon Wong, Prof.

Tan Tock Seng Hospital

Not yet recruiting

Singapore, Singapore, 308433 Contact: Ernest Kwek, Prof. 006562566011 Ernest_Kwek@ttsh.com.sg Principal Investigator: Ernest Kwek, Prof.

Spain Hospital Son LLatzer

Not yet recruiting

Palma de Mallorca, Balearic Island, Spain, 07198 Contact: Carlos Perez-Uribarri, MD 0034609440220 cperezhsll@gmail.com Principal Investigator: Carlos Perez-Uribarri, MD Hospital Universitario Costa del Sol

Not yet recruiting

Marbella, Spain, 29603 Contact: Enrique Guerado, Prof. 0034607143543 eguerado@telefonica.net Principal Investigator: Enrique Guerado, Prof.

www.aocid.org

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Thailand Bhumibol Adulyadej Hospital

Not yet recruiting

Bangkok, Thailand, 10220 Contact: Rahat Jarayabhand, MD 006625347366 nutrahat@hotmail.com Principal Investigator: Rahat Jarayabhand, MD Hospital Medical Center Bangkok

Not yet recruiting

Bangkok, Thailand, 10310 Contact: Pannida Wattanapanom, MD 006627551012 orthopedic.co@bgh.co.th Principal Investigator: Pannida Wattanapanom, MD

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator:

Michael Blauth, Professor Medical University of Innsbruck

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02297581 Other Study ID Numbers:

GFC

Study First Received:

November 17, 2014

Last Updated:

November 28, 2014

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Health Authority:

Austria: Ethikkommission Netherlands: Medical Ethics Review Committee (METC) Spain: Comité Ético de Investigación Clínica United States: Institutional Review Board Thailand: Institutional Review Board Singapore: Institutional Review Board

Keywords provided by AO Clinical Investigation and Documentation: Geriatrics [MeSH] Quality of life [MeSH] Mortality [MeSH] Osteoporotic fractures [MeSH] Hip fractures [MeSH] Complications Cost benefit analysis [MeSH]

Additional relevant MeSH terms: Fractures, Bone Hip Fractures Femoral Fractures

Hip Injuries Leg Injuries Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

www.aocid.org

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Focused Registry SmartFix (FRSmartFix) This study is not yet open for participant recruitment. (see Contacts and Locations) Verified January 2015 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02094209 First received: March 18, 2014 Last updated: January 16, 2015 Last verified: January 2015

Purpose 20 patients having received an AO large external fixator at the tibia will be equipped with a data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 6 months by means of a strain gauge. Several parameters are calculated from the recorded change in the strain signal and are stored at a regular interval.

Condition

Intervention

Fracture of Shaft of Tibia

Device: SmartFix

Study Type:

Observational [Patient Registry]

Study Design:

Observational Model: Case-Only Time Perspective: Prospective

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Target Follow-Up Duration: 6 Months Official Title:

Clinical Data Collection With a Novel Biofeedback Technology for Continuous Monitoring of Bone Healing

Resource links provided by NLM: MedlinePlus related topics: Fractures U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Changes in Parameters derived from the AO Fracture Monitor during bone healing [ Time Frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ] [ Designated as safety issue: No ]

AO Fracture Monitor: o

Mean deformation amplitude per 6 hours

o

Mean deformation rate

o

Number of load-cycles

o

Histogram of patient activity (load intensity distribution) Secondary Outcome Measures:

•

Change in Pain during bone healing [ Time Frame: Preoperative, Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) ] [ Designated as safety issue: No ] Pain measured with visual analog scale (VAS)

•

Change in weight-bearing during bone healing [ Time Frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) ] [ Designated as safety issue: No ] Documentation of allowed weight-bearing

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•

Repeated reference deformation at a load of 20 / 30 kg [ Time Frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) ] [ Designated as safety issue: No ] Two reference deformation values are measured under a load 20 kg and 30 kg respectively. The patient steps with his injured leg on a bathroom scale and loads it first with the reference load of 20 kg. The investigator then starts the measurement of the corresponding deformation value. After an acoustic signal indicates the end of the measurement, the procedure is repeated with a reference load of 30 kg. If the patient is not able to put the required load on his leg (e.g. due to pain), the reference value should be measured at a lower load with a note of the actually applied load in the patient record.

•

Patient information [ Time Frame: Up to 4 weeks before surgery ] [ Designated as safety issue: No ]

o

Patient demographics

o

Comorbidities

•

Treatment information [ Time Frame: Discharge ] [ Designated as safety issue: No ]

o

Fracture classification according to AO and Gustilo

o

Reason for external fixator treatment

o

Previous treatment related to current injury, if any

o

Fixator configuration

•

Development of the radiological healing assessment: RUST system [ Time Frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) ] [ Designated as safety issue: No ] The Radiographic Union Score for Tibial fractures (RUST score) is a reliable score to assess the healing of tibial fractures. Each of the four cortices (anterior, posterior, medial and lateral) is given a value from 1 to 3, depending on the presence of a callus and the visibility of the fracture line. The sum of the individual cortical scores results in a RUST value between 4 (definitely not healed) to 12 (definitely healed).

To investigate, whether patient activity as measured by the AO Fracture Monitor correlate with the radiological assessed course of healing.

Estimated Enrollment:

20

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Study Start Date:

February 2015

Estimated Study Completion Date:

March 2018

Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure) Intervention Details: Device: SmartFix AO Fracture Monitor attached postoperatively to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 4 months by means of a strain gauge.

Detailed Description: Maturation of fracture callus leads to unloading of the fracture fixation hardware due to an increased load-share of the repair tissue. A novel data logger device (AO Fracture Monitor) continuously measures the decline in fixation hardware deflection under physiological loading as indirect indicator for the healing progress. Parameters obtained from the data logger device carry potential to significantly improve the assessment of fracture healing in the future. Meaningful interpretation of measurements requires a set of clinical reference data.

20 patients having received an AO large external fixator at the tibia will be equipped with a data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 4 months by means of a strain gauge. Several parameters are calculated from the recorded change in the strain signal and are stored at a regular interval. Data is collected from the AO Fracture Monitor at follow-up visits of the patient by wireless data transfer. Together with additional variables such as treatment details, fracture healing and pain reported by the patient, the collected data is used to build up a database. Data from the AO Fracture Monitor will be correlated with patient data to investigate the relevance and reliability of the data derived from the AO Fracture Monitor.

In this phase, the study does not imply changes on the operational treatment, nor does it allow for therapeutic consequences based on the derived data.

Eligibility Ages Eligible for Study:

18 Years and older

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Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Patients with Tibia shaft fracture and external fracture fixation (AO large external fixator).

Patients capable of at least partial weight-bearing (or expected to do so in the course of healing).

Criteria Inclusion Criteria: •

Age 18 years and older

•

Diagnosis of Femoral or tibial shaft fracture

•

External fracture fixation with AO large external fixator

•

Capable of at least partial weight-bearing

•

Informed consent obtained, i.e.:

o

Ability to understand the content of the patient information/Informed Consent Form

o

Willingness and ability to participate in the Focused Registry according to the Registry Plan (RP)

o

Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria: Preoperative exclusion criteria: •

External fixation as temporary stabilization

•

Any not medically managed severe systemic disease

•

Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment

•

Prisoner

•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

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Intraoperative exclusion criteria: • Intraoperative decision to use implants other than the device under investigation

Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT02094209.

Locations Germany Berufsgenossenschaftliche Unfallklinik

Not yet recruiting

Tübingen, Baden Württemberg, Germany, 72076 Contact: Dankward Höntzsch, Professor +49 172 7403691 hoentzsch@tonline.de Principal Investigator: Dankward Höntzsch, Professor

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator:

Dankward Höntzsch, Professor

Berufsgenossenschaftliche Unfallklinik Tübingen

More Information

No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02094209

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Other Study ID Numbers:

FRSmartFix

Study First Received:

March 18, 2014

Last Updated:

January 16, 2015

Health Authority:

Germany: Ethics Commission

Keywords provided by AO Clinical Investigation and Documentation: External Fixation Tibial fracture Fracture healing

ClinicalTrials.gov processed this record on February 12, 2015.

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A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures (DMFx) This study is not yet open for participant recruitment. (see Contacts and Locations) Verified February 2015 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Collaborator: AOCMF Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02341443 First received: December 4, 2014 Last updated: February 2, 2015 Last verified: February 2015

Purpose Mandibular fractures represent approximately 50% of the total facial fractures and are commonly (more than half) presented in more than one location. A few simple fractures can be treated using a conservative approach. More often, however, mandibular fractures require stabilization using open reduction and internal fixation.

Simple mandibular fractures can be treated using non-rigid fixation techniques that rely on the load-sharing principle, by which stabilization is accomplished with both fixation devices and bone surfaces. On the other hand, more complex fractures with continuity defects or comminuted need to be handle using rigid fixation where the device assumes all the forces (load-bearing principle). These approaches are well established, whereas the level of evidence for the treatment of bilateral double mandibular fractures (DMF) is still scarce. In fact, which surgical treatment, or combination of treatments, leads to the best outcome and the lowest rate of complications in bilateral DMFs is an open question.

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The purpose of this study is to assess the complication rate in patients suffering from bilateral DMF treated either using non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side.

Condition

Intervention

Mandibular Fractures

Procedure: Implants

Study Type:

Interventional

Study Design:

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Official Title:

A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures

Resource links provided by NLM: MedlinePlus related topics: Fractures U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: â&#x20AC;˘

Number of anticipated procedure- or condition-related Adverse Events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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•

Degree of displacement of the fracture [ Time Frame: Pre-operatively (Day -1) ] [ Designated as safety issue: No ]

•

Location of the tooth with respect to the line of fracture [ Time Frame: Pre-operatively (Day -1) ] [ Designated as safety issue: No ]

•

Mechanism of production of the fracture: [ Time Frame: Pre-operatively (Day -1) ] [ Designated as safety issue: No ]

•

Time in days between the occurrence of the injury and the surgery [ Time Frame: Intraoperatively (Day 0) ] [ Designated as safety issue: No ]

•

Length of the surgery [ Time Frame: Intraoperatively (Day 0) ] [ Designated as safety issue: No ] Time in minutes from the first incision to skin closure

•

Length of the hospital stay [ Time Frame: Intraoperatively (Day 0) ] [ Designated as safety issue: No ] Time in days between the admission and the discharge of the (acute) hospital

•

Characteristics of the hardware [ Time Frame: Intraoperatively (Day 0) ] [ Designated as safety issue: No ] Characteristics of the hardware/device used to reduce the fracture concerning its shape, thickness and number or screws

•

Use of antibiotics [ Time Frame: Intraoperatively (Day 0) ] [ Designated as safety issue: No ] Administration of antibiotics during surgery

•

Difficulty of application of the hardware [ Time Frame: Intraoperatively (Day 0) ] [ Designated as safety issue: No ] Surgeon's own assessment of difficulty of application of the hardware from very easy to very difficult

•

Dysfunction of the mandible [ Time Frame: 6 weeks, 3 months ] [ Designated as safety issue: No ] Helkimo Index

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Estimated Enrollment:

314

Study Start Date:

May 2015

Estimated Study Completion Date:

May 2018

Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure) Arms

Assigned Interventions

Experimental: Rigid

Procedure: Implants

Surgery using mandibulo-maxillary fixation, implants providing rigid fixation on most anterior fracture and non-rigid fixation on the most posterior fracture.

Experimental arm: Rigid Surgical treatment using arch bars and according to the following fixation: Rigid fixation on one side (most anterior fracture) and non-rigid fixation on the other (most posterior fracture).

Active comparator: Non-rigid Surgical treatment using arch bars and according to the following fixation: Non-rigid fixation on both fracture sides.

Whereas non-rigid fixation is defined as a single miniplate of â&#x2030;¤1.00 mm thickness, and rigid fixation is defined as a single plate of â&#x2030;Ľ1.25 mm thickness, a combination of 2 plates or a 3D geometric plate.

Other Name: Open reduction and internal fixation

Active Comparator: Non-rigid

Procedure: Implants

Surgery using mandibulo-maxillary fixation and implants providing nonrigid fixation on both fracture sides.

Experimental arm: Rigid Surgical treatment using arch bars and according to the following fixation: Rigid fixation on one side (most anterior fracture) and non-rigid fixation on the other www.aocid.org

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(most posterior fracture).

Active comparator: Non-rigid Surgical treatment using arch bars and according to the following fixation: Non-rigid fixation on both fracture sides.

Whereas non-rigid fixation is defined as a single miniplate of ≤1.00 mm thickness, and rigid fixation is defined as a single plate of ≥1.25 mm thickness, a combination of 2 plates or a 3D geometric plate.

Other Name: Open reduction and internal fixation

Detailed Description: Prospective data will be collected in 314 patients suffering from bilateral (double) mandibular fracture randomly treated either with non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side. This is a study where patients will be treated per randomization to one of the two established treatments and followed for further clinical examination postoperatively at 6 weeks and 3 months after the intervention.

Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria Inclusion Criteria: •

Age 18 years or older at the date of the surgery

•

Diagnosis of bilateral (double) mandibular fracture located in:

o

Angle and body or

o

Angle and symphysis or

o

Body and symphysis www.aocid.org

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•

Dentition: Patients must have most of their maxillary and mandibular teeth present and it must be possible to identify proper occlusion. The application of intraoperative Mandibulo-maxillary fixation (MMF) using arch bars must be possible

•

Ability to understand the content of the patient information / Informed Consent Form

•

Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)

•

Signed and dated IRB/EC-approved written informed consent

Exclusion Criteria: •

Fractures displaying continuity defect or comminution

•

Fractures showing clinical signs of infection at presentation

•

Edentulous mandible fracture

•

Fractures requiring an extra-oral surgical approach

•

Concomitant maxillary fractures

•

Concomitant condylar fracture

•

Prior surgical treatment of the mandibular fracture(s)

•

Atrophy of the mandible (<20 mm vertical height) at the level of the fracture(s)

•

Polytrauma (i.e. severe injuries leading to life-threatening condition)

•

Prisoners

•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT02341443.

Contacts Contact: Víctor Díaz, PhD +41 81 414 2507 victor.diaz@aofoundation.org Contact: Andreas Faeh

andreas.faeh@aofoundation.org

Locations United States, Texas

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UT Health Science Center at San Antonio

Not yet recruiting

San Antonio, Texas, United States, 78229-3900 Contact: Edward Ellis III, DDS MS Finland Helsinki University Hospital

Not yet recruiting

Helsinki, Finland, 00029 Contact: Risto Kontio, MD DDS PhD

Sponsors and Collaborators AO Clinical Investigation and Documentation AOCMF

Investigators Principal Investigator:

Risto Kontio, MD DDS PhD

Helsinki University Hospital

Principal Investigator:

Edward Ellis III, DDS MS

UT Health Science Center at San Antonio

More Information Additional Information: Sponsor's website

No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02341443

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Other Study ID Numbers:

CIP_DMFx_V1.0

Study First Received:

December 4, 2014

Last Updated:

February 2, 2015

Health Authority:

Finland: Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation: bilateral double mandibular fractures rigid fixation no-rigid fixation jaw

Additional relevant MeSH terms: Fractures, Bone Mandibular Fractures Craniocerebral Trauma Facial Injuries

Jaw Fractures Maxillofacial Injuries Skull Fractures Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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MobiChina - A Prospective Multicenter Cohort Study This study is not yet open for participant recruitment. (see Contacts and Locations) Verified November 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02296086 First received: November 14, 2014 Last updated: November 18, 2014 Last verified: November 2014

Purpose The study will assess the difference in functionality between early vs. standard mobilization after hip fracture in the Chinese population.

Condition Unstable Fracture Hip Fracture

Study Type:

Observational

Study Design:

Observational Model: Cohort Time Perspective: Prospective

Official Title:

A Prospective Multicenter Cohort Study to Evaluate the Effect of Early Mobilization of Patients After Hip Fracture Fixation on

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Functional Outcomes in the Chinese Population

Resource links provided by NLM: MedlinePlus related topics: Fractures Hip Injuries and Disorders U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Modified Barthel Index [ Time Frame: 6 weeks postoperative ] [ Designated as safety issue: No ] Investigator completed score Secondary Outcome Measures:

•

Modified Barthel Index [ Time Frame: Baseline ] [ Designated as safety issue: No ] Modified Barthel Index is retrospectively assessed for the pre-injury status using an investigator completed score

•

Modified Barthel Index [ Time Frame: 12 weeks postoperative ] [ Designated as safety issue: No ] Investigator completed score

•

Immobilization-related adverse events [ Time Frame: From surgery to 1 year followup ] [ Designated as safety issue: No ] Immobilization-related adverse events:

o

Pneumonia

o

Lung embolism

o

Pressure sores/ulcers

o

Urinary tract infections

•

Fixation failures [ Time Frame: From surgery up to 1 year follow-up ] [ Designated as safety issue: No ] www.aocid.org

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As assessed by the local investigator •

Any other adverse events [ Time Frame: From surgery up to 1 year follow-up ] [ Designated as safety issue: No ]

•

Mortality [ Time Frame: From surgery up to 1 year postoperative ] [ Designated as safety issue: No ]

•

Muscle loss [ Time Frame: From surgery up to 1 year follow-up ] [ Designated as safety issue: No ] Calf circumference measurement comparison: Loss calculated in %

•

Time to achieve partial and full weight bearing [ Time Frame: From surgery to 1 year follow-up ] [ Designated as safety issue: No ] Will be assessed during the patient interview

•

Duration of hospital stay [ Time Frame: For the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]

•

Numbers of re-admissions to the hospital [ Time Frame: From surgery to 1 year follow-up ] [ Designated as safety issue: No ]

•

Quality of life: EuroQoL (EQ-5D) [ Time Frame: 12 weeks postoperative ] [ Designated as safety issue: No ] Quality of life questionnaire using the EQ-5D

•

Residential status [ Time Frame: Baseline to 1 year follow-up ] [ Designated as safety issue: No ] Will be assessed during the patient interview

Estimated Enrollment:

248

Study Start Date:

February 2015

Estimated Study Completion Date:

March 2017

Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

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Groups/Cohorts Group I Study sites in which patients perform early mobilization as per local standard of care, which is as follows: 2 days (at the latest) after surgery: Transfer from the bed to a sitting chair for the first time 4 (± 2) days after surgery: Stand up and put both feet on the ground for the first time (walking aids allowed) 5 (± 2) days after surgery: Walking (at least partial weight bearing, walking aids allowed) The patients are instructed by the investigator at the hospital about a standardized mobilization program to be followed at home Group II Study sites in which patients start walking (i.e. partial weight bearing, walking aids allowed) more than 7 days after surgery as per local standard of care

Detailed Description: The primary objective of this prospective observational cohort study is to assess the difference in functionality between Group I and II (see mobilization regimens for the two groups above) at 6 weeks using the modified Barthel Index in the Chinese population.

The allocation of patients to the two groups will be performed on a clinic level: 50% of patients will be recruited by study sites in Group I (early mobilization). The other 50% of patients will be recruited by study sites in Group II. The sites are carefully selected after evaluating their standard procedures of mobilizing elderly patients after hip fractures. This process is documented using formal site selection questionnaires.

The modified Barthel Index is estimated at 75 points for Group II and at 85 points for Group I. Patients aged 65 years and older with unstable intertrochanteric fractures (AO 31 A2 or A3) treated with an intramedullary nail will be included in this study.

The study visits will be defined as preoperative, surgery, discharge, 6 (± 2) weeks and 12 (± 2) weeks follow-up (FU) visits. Furthermore, there will be a telephone contact 12 months (± 1 month) postsurgery.

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Eligibility Ages Eligible for Study:

65 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Primary care clinic

Criteria Inclusion Criteria: •

Age 65 and older

•

Diagnosis of an unstable intertrochanteric fractures (AO 31- A2 or A3) treated with an intramedullary nail

•

Ability to walk independently or with a walking aid prior to injury

•

Informed consent obtained, i.e.: Ability of the patient to understand the content of the patient information / Informed Consent Form and signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent

Exclusion Criteria: •

Severe dementia

•

Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

•

Prisoner

•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT02296086.

Locations

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China, Beijing JiShuiTan Hopsital

Not yet recruiting

Beijing, Beijing, China Contact: Manyi Wang, MD +86 13501269757 jstwang@126.com Principal Investigator: Manyi Wang, MD Sub-Investigator: Minghui Yang, MD China, Hebei 3th Hospital of Hebei Medical University of Hebei

Not yet recruiting

Hebei, Hebei, China Contact: Pengcheng Wang, Prof +86031188603608 wpcheng999@hotmail.com Principal Investigator: Pengcheng Wang, Prof.

Sub-Investigator: Dong Ren, Prof.

China DCN Hospital

Not yet recruiting

Beijing, China Contact: Liu Li 86-10-51339392 jb122620@163.com Principal Investigator: Liu Yi, Prof.

Sub-Investigator: Lv You West China Hospital of Sichuan University

Not yet recruiting

Chengdu, China Contact: Zhou Xiang, Prof. +86 28 85422114 xiangzhou15@hotmail.com Principal Investigator: Zhou Xiang, Prof.

Sub-Investigator: Duan Xin, MD

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Yunnan Second People Hospital

Not yet recruiting

Kunming, China Contact: Chen Zhong, MD +86 13708801238 13708801238@163.com Principal Investigator: Chen Zhong, MD Sub-Investigator: Ou Yi Nantong University 1st Affiliated Hospital

Not yet recruiting

Nantong, China Contact: Liu Fan, Prof. +86-513-81161526 iufan19575@aliyun.com Principal Investigator: Liu Fan, Prof.

Sub-Investigator: Wang Hong, Prof.

Shanghai Sixth People Hospital

Not yet recruiting

Shanghai, China Contact: Changqing Zhang, Prof. 86-21-64369181 shiliukjc@sohu.com Principal Investigator: Changqing Zhang, Prof.

Sub-Investigator: Xiaolin Li, Prof.

Hong Hui Hospital

Not yet recruiting

Xi`an, China Contact: Kun Zhang, Prof. +86 029-87800002 hhyyzk@126.com Principal Investigator: Kun Zhang, Prof.

Sub-Investigator: Zhe Song, MD Hong Kong Queen Mary Hospital

Not yet recruiting

Hong Kong, Pokfulam, Hong Kong Contact: Frankie Leung, MD +852 2855 4021 klleunga@hku.hk

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Principal Investigator: Frankie Leung, MD Sub-Investigator: Lau Tak Wing, MD Queen Elisabeth Hospital

Not yet recruiting

Hong Kong, Hong Kong Contact: Wilson LI, MD 29588888 tiukl@hotmail.com Principal Investigator: Wilson Li, MD Sub-Investigator: Tiu Kwok Leung, MD

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator:

Frankie Leung, MD Queen Mary Hospital, Hong Kong

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02296086 Other Study ID Numbers:

MobiChina

Study First Received:

November 14, 2014

Last Updated:

November 18, 2014

Health Authority:

China: Ethics Committee Hong Kong: Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation: Geriatrics [MeSH] www.aocid.org

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Hip fractures [MeSH] China [MeSH] Early ambulation [MeSH] Immobilization [MeSH]

Additional relevant MeSH terms: Fractures, Bone Hip Fractures Femoral Fractures

Hip Injuries Leg Injuries Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures This study is currently recruiting participants. (see Contacts and Locations) Verified July 2014 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01751633 First received: December 14, 2012 Last updated: July 24, 2014 Last verified: July 2014

Purpose Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.

Condition

Intervention

Single Level Stable Thoracolumbar Fracture Type AO A3 Multiple Level Stable Thoracolumbar Fracture Type AO A3

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Procedure: Surgical Procedure: Conservative treatment

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Study Type:

Observational

Study Design:

Observational Model: Cohort Time Perspective: Prospective

Official Title:

Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study

Resource links provided by NLM: MedlinePlus related topics: Fractures Health Facilities U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: 6 week follow up ] [ Designated as safety issue: No ] Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ) Secondary Outcome Measures:

•

Back pain related disability (Roland-Morris Disability Questionnaire RMDQ) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ]

•

Pain (Numeric Rating Scale (NRS)) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU ] [ Designated as safety issue: No ]

•

Radiologic progress taking into account RX, CT and optionally MRI [ Time Frame: baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]

•

Quality of return to work (Denis Work Scale) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ]

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•

Time to return to work [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ]

•

Conservative treatment failure rate (eg, change to surgical treatment) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ]

•

Rates of local adverse events (AE) [ Time Frame: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up ] [ Designated as safety issue: No ] Estimated Enrollment:

140

Study Start Date:

January 2013

Estimated Study Completion Date:

December 2016

Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure) Groups/Cohorts

Assigned Interventions

Surgical treatment

Procedure: Surgical

Surgical treatment according to one of the following:

Other Names: • Posterior open approach

Posterior open approach Posterior minimally-invasive surgery (MIS) approach The choice of the approach will be left upon the surgeon's discretion

• Posterior minimally-invasive surgery (MIS) approach

Conservative treatment

Procedure: Conservative treatment

Conservative treatment according to hospital's standard of care

Other Names: Conservative treatment according to hospital's standard of care : - Bed rest followed by immobilization with: - Custom-moulded or prefabricated total body contact thoracolumbosacral orthosis (TLSO)

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- Thermoplastic removable brace, Jewett hyperextension braces, Anterior hyperextension brace (ASH), TaylorKnight brace - Plaster of Paris (POP)

Eligibility Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population 140 patients with thoracolumbar fractures will be assigned to either conservative or surgical treatment depending on the surgeon's decision. Patients will be treated at each institution per standard of care. Surgeons will use their expertise and preferences to determine the method of surgical or conservative intervention.

Criteria Inclusion Criteria: •

Age 18-65 years

•

Diagnosis of single or multiple stable thoracolumbar fracture(s)

o

Level T10- L3

o

Type AO A3 or A4

o

Radiologically confirmed by Rx or CT

•

Fracture induced kyphotic deformity lower or equal to 20-35 degrees

•

Definitive treatment (surgical or conservative) within 10 days after injury

•

American Spinal Injury Association (ASIA) Impairment Scale = E (normal )

•

Ability to understand patient information / informed consent form

•

Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs)

•

Signed informed consent www.aocid.org

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Exclusion Criteria: •

Open fracture

•

Polytrauma

•

Pathologic fracture

•

Disruption of the posterior ligamentous complex between T10 and L3

•

Clinically evident osteoporosis as assessed by the investigator

•

Spinal luxation

•

Associated severe lesions as assessed by the investigator

•

Spinal lesion due to gun or projectile

•

Pre-existing spinal column deformity

•

Prior spinal surgeries

•

BMI > 40 kg/m2

•

Any severe medically not managed systemic disease

•

Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reli-able assessment

•

Pregnancy or women planning to conceive within the study period

•

Prisoner

•

Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01751633.

Contacts Contact: Victor Diaz, Dr.

0041814142507

victor.diaz@aofoundation.org

Locations Brazil Hospital Universitaria Cajuru

Recruiting

Curitiba, Brazil

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Contact: Emiliano Vialle, Dr. Principal Investigator: Emiliano Vialle, Dr. Hospital Cristo Redentor

Recruiting

Porto Alegre, Brazil Contact: Asdrubal Falavigna, Dr. Principal Investigator: Asrubal Falavigna, Dr. Not yet recruiting

Hospital Santa Marcelina São Paulo, Brazil Contact: Osmar Moraes, Dr. Principal Investigator: Osmar Moraes, Dr. Chile Hospital Cristo Redentor

Recruiting

Santiago de Chile, Chile Contact: José Flediermann, Dr. Principal Investigator: José Fleidermann, Dr. Czech Republic Krajská nemocnice Liberec

Recruiting

Liberec, Czech Republic Contact: Roman Harcuba, Dr. Principal Investigator: Roman Harcuba, Dr. Germany Klinikum rechts der Isar der Technischen Universität München

www.aocid.org

Recruiting

134

Munich, Germany Contact: Bernhard Meyer, Prof.

Principal Investigator: Bernhard Meyer, Prof.

Italy Azienda Ospedaliero - Universitaria Policlinico

Recruiting

Catania, Italy Contact: Giuseppe Barbagallo, Prof.

Principal Investigator: Giuseppe Barbagallo, Prof.

Portugal Hospital Garcia e Orta, EPE

Recruiting

Almada, Portugal Contact: Manuel Cunha ĂŠ Sa, Dr. Principal Investigator: Manuel Cunha ĂŠ Sa, Dr.

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator:

Giuseppe Barbagallo, MD

Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy

Principal Investigator:

Emiliano Vialle, MD

Catholic University of Parana - Curitiba, Brazil

More Information No publications provided.

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135

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01751633 Other Study ID Numbers:

Spine FA3

Study First Received:

December 14, 2012

Last Updated:

July 24, 2014

Health Authority:

Italy: Ethics Committee Germany: Ethics Commission Portugal: Ethics Committee for Clinical Research Czech Republic: Ethics Committee Netherlands: Independent Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation: Burst fractures Thoracolumbar fracture management Thoracic or Lumbar Vertebrae/injuries Quality of life [MeSH] Functional outcome Thoracic or Lumbar Vertebrae/surgery [MeSH] Spinal Fusion/methods [MeSH]

Additional relevant MeSH terms: Fractures, Bone Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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A Focused Registry on Anterior Cervical Interbody Spacer ACIS This study is currently recruiting participants. (see Contacts and Locations) Verified January 2015 by AO Clinical Investigation and Documentation Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT02016794 First received: December 10, 2013 Last updated: January 13, 2015 Last verified: January 2015

Purpose Degenerative cervical spine conditions lead to chronic neck and arm pain. Surgical treatment may require anterior decompression and fusion, which usually is established with a cage implant. The Anterior Cervical Interbody Spacer (ACIS) is such a cage.

Condition Degenerative Cervical Spine

Study Type:

Observational [Patient Registry]

Study Design:

Observational Model: Case-Only Time Perspective: Prospective

Target Follow-Up Duration: 6 Months

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Official Title:

A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration

Resource links provided by NLM: MedlinePlus related topics: Neck Injuries and Disorders U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Effect of neck pain on everyday life measured by the Neck Disability Index (NDI). [ Time Frame: 6 months ] [ Designated as safety issue: No ] Secondary Outcome Measures:

•

Pain [ Time Frame: Baseline; 1-2days; 6 weeks; 6 months ] [ Designated as safety issue: No ] Numeric Rating Scale

•

Handling details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ] easiness of using ACIS, overall satisfaction with ACIS, time of surgery

•

Length of Hospital Stay [ Time Frame: Expected average of 5 days ] [ Designated as safety issue: No ] From the day of the surgery until the day of discharge

•

Adverse Events [ Time Frame: Intra and post operative ] [ Designated as safety issue: Yes ] Estimated Enrollment:

25

Study Start Date:

February 2014

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Estimated Study Completion Date:

November 2015

Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure) Groups/Cohorts Patients Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels

Eligibility Ages Eligible for Study:

21 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population Patients undergoing surgery for degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels

Criteria Inclusion Criteria: •

Age 21 years or older

•

Degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels

•

Degenerative cervical disc disease C3 through Th1 or

•

Ruptured and herniated discs C3 through Th1

•

Ability to understand the content of the patient information / informed consent form

•

Willingness and ability to participate in the registry according to the registry plan (RP)

•

Signed and dated IRB / EC-approved written informed consent

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Exclusion Criteria: •

Spinal tumor

•

Osteoporosis

•

Cervical trauma and instability

•

Any not medically managed severe systemic disease (ie. infection)

•

Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

•

Pregnancy or women planning to conceive within the registry period

•

Prisoner

•

Participation in any other medical device or medicinal product clinical investigation or registry within the previous month that could influence the results of the present registry

Intraoperative exclusion criteria: •

Intraoperative decision to use implants other than the device under investigation Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT02016794.

Contacts Contact: Andreas Faeh

andreas.faeh@aofoundation.org

Locations Belgium AZ Klina

Recruiting

Brasschaat, Belgium, 2020 Contact: Robert Hes, Dr. Principal Investigator: Robert Hes, Dr. AZ Sint Maarten

Recruiting

Duffel, Belgium, 2570 www.aocid.org

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Contact: Anton Veyt, Dr. Principal Investigator: Anton Veyt, Dr. Sponsors and Collaborators AO Clinical Investigation and Documentation More Information

No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT02016794 Other Study ID Numbers:

FR_ACIS

Study First Received:

December 10, 2013

Last Updated:

January 13, 2015

Health Authority:

Belgium: Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation: cervical neck interbody decompression spacer fusion degenerative implant pain

ClinicalTrials.gov processed this record on February 12, 2015.

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Ongoing studies â&#x20AC;&#x201C; active, not recruiting

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Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation This study is ongoing, but not recruiting participants.

Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01473082 First received: November 10, 2011 Last updated: January 13, 2015 Last verified: January 2015

Purpose The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.

Condition

Intervention

Phase

Hip Fractures Closed Fracture of Hip

Device: PFNA Augmentation (Synthes) Device: PFNA (Synthes)

Phase 4

Study Type:

Interventional

Study Design:

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

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Official Title:

Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial

Resource links provided by NLM: MedlinePlus related topics: Fractures Health Facilities Hip Injuries and Disorders U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

Mobility measured with the "timed up & go"-test during hospital stay. [ Time Frame: 5 to 7 days postoperative ] [ Designated as safety issue: No ] The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again. Patient-perceived pain and exertion will be assessed after the test.

Secondary Outcome Measures:

•

Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only). [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

•

Pain [ Time Frame: one year ] [ Designated as safety issue: No ] Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.

•

Duration of hospital stay [ Time Frame: one year ] [ Designated as safety issue: No ]

•

Walking ability [ Time Frame: one year ] [ Designated as safety issue: No ] Parker Mobility Score

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•

Return to pre-fracture residential status [ Time Frame: one year ] [ Designated as safety issue: No ]

•

Timed up & go-test at follow-ups [ Time Frame: one year ] [ Designated as safety issue: No ] The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again.

•

Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ] EuroQol-5D

•

Local adverse events and revision rate [ Time Frame: one year ] [ Designated as safety issue: No ] Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events

•

Systemic adverse events [ Time Frame: one year ] [ Designated as safety issue: No ]

•

Implant migration [ Time Frame: one year ] [ Designated as safety issue: No ] Measured at the CT in a subgroup only

•

Mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

•

Fracture risk prior to injury [ Time Frame: 1 week prior to operation ] [ Designated as safety issue: No ] Measured with the Fracture Risk Assessment Tool (FRAX)

•

Functional independence [ Time Frame: 1 week prior to operation ] [ Designated as safety issue: No ] Measured with the Barthel Index

•

Comorbidity [ Time Frame: 1 week prior to operation ] [ Designated as safety issue: No ] Charlson Comorbidiy Index

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Enrollment:

251

Study Start Date:

February 2012

Estimated Study Completion Date:

December 2015

Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure) Arms

Assigned Interventions

Active Comparator: PFNA

Device: PFNA (Synthes)

Proximal Femoral Nail Antirotation (PFNA Synthes)

Proximal Femoral Nail Antirotation (PFNA) Other Names: PFNA length 240 mm PFNA small length 200 mm PFNA xs length 170 mm PFNA long lengths 300-420 mm

Active Comparator: PFNA Augmentation Proximal Femoral Nail Antirotation PFNA Augmentation (Synthes) with Traumacem V+ Synthes

Device: PFNA Augmentation (Synthes) Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+) Other Names: PFNA Augmentation (Synthes) length 240 mm PFNA Augmentation (Synthes) small length 200 mm PFNA Augmentation (Synthes) xs length 170 mm PFNA Augmentation (Synthes) long lengths 300-420 mm

Detailed Description: www.aocid.org

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To avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. Biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. In clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. The purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a PFNA and augmentation can better be mobilized than patients without augmentation.

In particular, it will be measured whether patients with a PFNA Augmentation can walk faster than the non-augmented patients, measured with the Timed up and Go test.

Eligibility Ages Eligible for Study:

75 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria Inclusion Criteria: •

Age 75 years and older

•

Closed unstable trochanteric fracture: AO 31 - A2 and A3

•

Low energy trauma (e.g.fall from standing height)

•

Definitive fracture fixation within 72 hrs. after admission

•

Indication for PFNA fixation (with or without augmentation)

•

Ability to walk independently (walking aids are allowed) prior to injury

•

Signed written informed consent and agreement to attend the planned FUs

•

Able to understand and read country national language at an elementary level

Exclusion Criteria: •

Pathologic fracture

•

Polytrauma

•

Any additional fracture

•

Open fracture

•

Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment www.aocid.org

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•

Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years

•

ASA class V and VI

•

Any implant at the same hip

•

Hemiplegia

•

Patients with legal guardian

•

Patients who have participated in any other device or drug related clinical trial that could influence the results of the present study within the previous month

•

Fractures and injuries opening into the articulation and vascular structure

•

Infection

•

Patients with clotting disorders

•

Patients with severe cardiac and / or pulmonary insufficiency

•

Patients with known hypersensitivity or allergy to any of the components of Traumacem V+ cement (Polymethyl methacrylate / acrylate, zirconium dioxide, hydroxyapatite,benzoyl peroxide, methyl methacrylate,hydroquinone, N,N-dimethyl-ptoluidine)

•

Perforation of the femoral head into the joint with the guide wire used for the PFNA blade

•

Risk of potential leakage into the joint identified by using contrast fluid (PFNA Augmentation group only)

•

Intraoperative decision to use implants other than PFNA Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01473082.

Locations Austria Medical University of Innsbruck Innsbruck, Austria, 6020 Belgium KUL Univ. Ziekenhuizen Leuven

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Leuven, Belgium, 3000 Germany BGU Tübingen Tübingen, Germany, 72076 University of Ulm Ulm, Germany, 89075 Sophien und Hufeland Klinikum GmbH Weimar, Germany, 99425 Israel Hadassah Medical Organization Jerusalem, Israel, 91120 Norway Sykehuset i Vestfold HF Tønsberg Tønsberg, Norway, 3103 Switzerland Cantonal Hospital Lucerne Lucerne, Switzerland, 6000 City Hospital Waid Zürich, Switzerland, 8037

Sponsors and Collaborators AO Clinical Investigation and Documentation

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Investigators Study Director:

Beate P. Hanson, MD

AO Clinical Investigation and Documentation, Davos, Switzerland

Principal Investigator:

Christian Kammerlander, MD

Medical University of Innsbruck, Austria

More Information

No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01473082 Other Study ID Numbers:

PFNA augmented

Study First Received:

November 10, 2011

Last Updated:

January 13, 2015

Health Authority:

Austria: Ethikkommission Belgium: Ethics Committee Germany: Ethics Commission Israel: Ethics Commission Norway: Ethics Committee Switzerland: Ethikkommission

Additional relevant MeSH terms: Fractures, Bone Fractures, Closed Hip Fractures Femoral Fractures

Hip Injuries Leg Injuries Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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Pilon Fracture Reduction and Functional Outcome This study is ongoing, but not recruiting participants.

Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01316289 First received: March 14, 2011 Last updated: January 13, 2015 Last verified: January 2015

Purpose This prospective case series will essentially examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation.

The plates used in this trial can be chosen according to the preferences of the surgeon.

Condition Pilon Fracture of Tibia

Study Type:

Observational

Study Design:

Observational Model: Case Control Time Perspective: Prospective

Official Title:

Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter

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Case Series

Resource links provided by NLM: MedlinePlus related topics: Fractures Leg Injuries and Disorders U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: â&#x20AC;˘

Examine the influence of reduction quality on the primary functional outcome (as assessed using the Foot and Ankle Ability Measure (FAAM)) of patients with pilon fractures treated with plate fixation. [ Time Frame: 2 years ] [ Designated as safety issue: No ] The most important predictors of functional outcome after pilon fracture will be identified by evaluating the influence of radiologically assessed parameters of reduction quality and other factors (age, high/low energy trauma, AO fracture type, open/closed fracture, delay between trauma and definitive fracture fixation) on the FAAM. In parallel, the radiological parameters will also be validated with respect to their reliability.

Secondary Outcome Measures:

â&#x20AC;˘

Patient outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]

o

Clinician-evaluated function of the ankle (Olerud and Molander score)

o

Trauma Outcomes Measure (TOM)

o

Time to full weight bearing without pain

o

Quality of life with Short Form-12 (SF-12) and EuroQol5 (EQ5)

o

Range of motion

o

Pain with the Numerical Rating Scale (NRS)

o

Return to work

o

Return to sports activities

o

Length of hospital stay

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•

Frequency and severity of osteoarthritis (OA) following pilon fractures [ Time Frame: 5 years ] [ Designated as safety issue: No ] Occurrence and severity of OA as radiologically assessed using the Bargon and Kellgren-Lawrence classification systems

•

Surgical details [ Time Frame: 1 year ] [ Designated as safety issue: No ]

o

Length of surgery (skin-to-skin time)

o

Type of implant used

o

Use of bone graft

o

Soft tissue or wound-related procedures (eg, debridement, free flap, local flap, split skin graft)

•

Pre- and postoperative treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ] Perioperative management data will include documentation of the use of thromboprophylaxis or prophylactic antibiotics, therapeutic antibiotics and pain medication including nonsteroidal antiinflammatory drugs (NSAID).

•

Frequency of local complications [ Time Frame: 5 years ] [ Designated as safety issue: No ] Bone, implant/surgery and soft tissue complications and revision surgery

•

Effect of prognostic factors on the occurrence of complications [ Time Frame: 5 years ] [ Designated as safety issue: No ] eg, soft tissue damage, fracture severity

•

To assess whether patient and surgeon expectations are met with regard to the trauma outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ] Trauma expectations factor (TEF) to assess the patient and surgeon expectations about the outcome of the treatment

Enrollment:

117

Study Start Date:

November 2011

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Estimated Study Completion Date:

March 2019

Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure) Detailed Description: A prospective case series to examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation. Radiological parameters including single/combined alignment and various articular measurements will also be validated according to their reliability. The sensitivity of the effects of reduction quality on functional outcome, and an extended evaluation of patient-rated functional and social outcomes as well as their outcome expectations will also be assessed as part of the secondary study aims.

Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population Patients with pilon fractures that fulfill the following inclusion and exclusion criteria

Criteria Inclusion Criteria: •

Age 18 years and older

•

Patients with a unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 - B1, B2 and B3 (partial intraarticular) AO 43 - C1, C2 and C3 (total intraarticular)

•

Definitive fracture fixation with a plate within 4 weeks after accident (Temporary fixation with an external fixator, cast or traction is allowed)

•

Signed written informed consent (by the patients) and agreement to attend the planned FU evaluations www.aocid.org

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Exclusion Criteria: •

Contralateral fracture of the distal half of the tibia/fibula/talus

•

Pathologic fracture

•

Severe Polytrauma: Injury Severity Score (ISS) > 28

•

Preexisting severe vascular disease (chronic venous insufficiency, chronic arterial occlusive disease)

•

Drug or alcohol abuse

•

American Society of Anesthesiologists (ASA) class V and VI

•

Inability to walk independently prior to injury event

•

Neurological and psychiatric disorders that would preclude reliable assessment

Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01316289.

Locations United States, Indiana Indiana Orthopaedic Hospital Indianapolis, Indiana, United States, 46202 United States, Minnesota University of Minnesota St. Paul, Minnesota, United States, 55101 United States, Mississippi University of Mississippi Medical Center Jackson, Mississippi, United States, 39216 United States, Washington

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Harborview Medical Center Seattle, Washington, United States, 98104 Austria Medical University Innsbruck Innsbruck, Austria, 6020 Brazil Universidade de S達o Paulo - Faculdade de Medicina Cerqueira Cesar - Sao Paulo, CEP, Brazil, 05403-010 Switzerland Cantonal Hospital Graubuenden Chur, Switzerland, 7000 Cantonal Hospital Luzern Luzern, Switzerland, 6000 Cantonal Hospital Winterthur Winterthur, Switzerland, 8401

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator:

Christoph Sommer, MD

Cantonal Hospital Graubuenden

Study Director:

Beate P. Hanson, MD

AO Clinical Investigation and Documentation, Davos, Switzerland www.aocid.org

156

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01316289 Other Study ID Numbers:

Pilon

Study First Received:

March 14, 2011

Last Updated:

January 13, 2015

Health Authority:

Austria: Ethikkommission Brazil: Ethics Committee Germany: Ethics Commission Switzerland: Ethikkommission United States: Institutional Review Board

Keywords provided by AO Clinical Investigation and Documentation: tibial fractures reduction quality pilon anatomical reduction functional outcome pilon fractures tibial plafond ankle joint

Additional relevant MeSH terms: Fractures, Bone Tibial Fractures Leg Injuries Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants (Orbita 3) This study is ongoing, but not recruiting participants.

Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01121159 First received: May 7, 2010 Last updated: January 16, 2015 Last verified: January 2015

Purpose Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.

Condition

Intervention

Orbital Floor Fracture Medial Orbital Wall Fracture

Procedure: orbital fracture repair

Study Type:

Observational

Study Design:

Observational Model: Cohort Time Perspective: Prospective

Official Title:

A Prospective Multicenter Study to Compare the Accuracy of Posttraumatic Orbital Reconstruction of the Medial Orbital Wall and/or the Orbital Floor With Preoperatively Preformed Versus Nonwww.aocid.org

158

preformed Orbital Plates

Resource links provided by NLM: MedlinePlus related topics: Fractures Plastic and Cosmetic Surgery U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: •

shape and volume assessing software [ Time Frame: up to 3 days after surgery ] [ Designated as safety issue: No ] A post-op CT or CBCT scan will be analyzed with specially developed software that can compare shape and volume of the reconstruced orbit to the uninjured orbit.

Secondary Outcome Measures:

•

shape and volume assessing software [ Time Frame: up to 3 days after surgery ] [ Designated as safety issue: No ] 6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit

•

Clinical tests to assess vision [ Time Frame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery ] [ Designated as safety issue: No ] Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests

•

Rate of complications [ Time Frame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery ] [ Designated as safety issue: No ] Complications will be documented at every follow-up

Estimated Enrollment:

170

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159

Study Start Date:

June 2010

Estimated Study Completion Date: February 2015 Primary Completion Date:

June 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts

Assigned Interventions

Preoperatively preformed orbital plates

Procedure: orbital fracture repair

Reconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custommade orbital implant

All patients will receive orbital fracture repair with one of the 4 specified implants

Non-preformed orbital plates

Procedure: orbital fracture repair

Reconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes)

All patients will receive orbital fracture repair with one of the 4 specified implants

Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population patients with fractures of the orbital floor and/or medial orbital wall in one of the study centers

Criteria Inclusion Criteria: 1. Patients â&#x2030;Ľ 18 years www.aocid.org

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2. Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor 3. Scheduled for reconstruction surgery with one of the following implants: o

MatrixMIDFACE Preformed Orbital Plate

o

Custom-made orbital implant

o

Orbital Floor Mesh Plate

o

SynPOR Titanium Reinforced Fan Sheet

4. At least partial sight in both eyes before the accident 5. Willingness and ability to participate in the study follow-up according to the protocol 6. Ability to understand and read local language at elementary level 7. Signed informed consent Exclusion Criteria: 1. Bilateral orbital fracture 2. Fractures of the orbital roof 3. Comminuted zygoma fracture 4. More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure 5. Previous dislocated orbital fractures on either side 6. Vision or diplopia not assessable 7. Injury of the globe 8. Neurological diseases with influence on eye motility or sight 9. Legal incompetence 10. Active malignancy 11. Life-threatening condition 12. Alcohol and drug abuse

Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01121159.

Locations United States, Texas

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University of Texas Health Science Center at San Antonio San Antonio, Texas, United States, 78229-3900 Germany Medizinische Hochschule Hannover Hannover, Niedersachsen, Germany, 30625 Universit채tsklinikum Freiburg Freiburg, Germany, 79106 Bundeswehrkrankenhaus Ulm Ulm, Germany, 89081 Singapore National University Hospital Singapore, Singapore, 119074 Spain Hospital de 12 Octubre Madrid, Spain, 28041

Sponsors and Collaborators AO Clinical Investigation and Documentation

Investigators Principal Investigator:

Niels Gellrich, Prof

Medizinische Hachschule Hannover

More Information

www.aocid.org

162

No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01121159 Other Study ID Numbers:

Orbita3

Study First Received:

May 7, 2010

Last Updated:

January 16, 2015

Health Authority:

Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms: Fractures, Bone Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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Surgical Treatment of Cervical Spondylotic Myelopathy This study is ongoing, but not recruiting participants.

Sponsor: AO Clinical Investigation and Documentation Collaborator: AOSpine International Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT00565734 First received: November 29, 2007 Last updated: July 30, 2014 Last verified: July 2014

Purpose The primary purposes of this study are to compare anterior and posterior surgical approach in treatment of CSM ad to compare variations in treatment and outcomes of CSM worldwide.

Condition Cervical Spondylotic Myelopathy

Phase Phase 4

Study Type:

Observational

Study Design:

Observational Model: Cohort Time Perspective: Prospective

Official Title:

An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy www.aocid.org

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Resource links provided by NLM: MedlinePlus related topics: Bone Marrow Diseases U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: â&#x20AC;˘

Surgical complications and neurological, functional, disease-specific and quality of life measures [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures: â&#x20AC;˘

Differences in patient presentation, treatment approaches and treatment outcomes among ethnic/racial groups, health care systems and regions of the world [ Time Frame: 24 months ] [ Designated as safety issue: No ] Estimated Enrollment:

375

Study Start Date:

November 2007

Estimated Study Completion Date:

September 2015

Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure) Groups/Cohorts Posterior surgical approaches Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM) Anterior surgical approaches

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Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM).

Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Patients with symptomatic CSM who referred for surgical consultation to the corresponding participating site's orthopedic or neurosurgery services will be eligible for this study.

Criteria Inclusion Criteria: •

Age > 18 years

•

Willing and able to give written informed consent to participate in the study

•

Willing and able to participate in the study follow-up according to the protocol

•

Willing and able to comply with post-operative management program

•

Understand and read country language at elementary level

•

Patients who undergo surgery for symptomatic CSM defined as a combination of one or more of the following symptoms:

•

Numb hands

•

Clumsy hands

•

Impairment of gait

•

Bilateral arm paresthesiae

•

l'Hermitte's phenomena

•

Weakness AND one or more of the following signs:

•

Corticospinal distribution motor deficits www.aocid.org

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•

Atrophy of hand intrinsic muscles

•

Hyperreflexia

•

Positive Hoffman sign

•

Upgoing plantar responses

•

Lower limb spasticity

•

Broad based, unstable gait

Exclusion Criteria: •

Asymptomatic CSM

•

Previous surgery for CSM

•

Active infection

•

Neoplastic disease

•

Rheumatoid arthritis

•

Ankylosing spondylitis

•

Trauma

•

Concomitant symptomatic lumbar stenosis

•

Pregnant women or women planning to get pregnant during the study period

•

Has a history of substance abuse (recreational drugs, alcohol)

•

Is a prisoner

•

Is currently involved in a study with similar purpose

•

Has a disease process that would preclude accurate evaluation (eg., neuromuscular disease, significant psychiatric disease)

•

Patients seen by other services (eg., physical medicine, neurology, family practice), managed conservatively and not referred for surgical consultation are ineligible.

Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00565734.

Locations Canada, Ontario Univerity of Toronto

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Toronto, Ontario, Canada, M5T 2S8

Sponsors and Collaborators AO Clinical Investigation and Documentation AOSpine International

Investigators Principal Investigator:

Michael Fehlings, MD, PhD University of Troronto

More Information

No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT00565734 Other Study ID Numbers:

CSM-I 07

Study First Received:

November 29, 2007

Last Updated:

July 30, 2014

Health Authority:

Canada: Ethics Review Committee

Additional relevant MeSH terms: Bone Marrow Diseases Hematologic Diseases

ClinicalTrials.gov processed this record on February 12, 2015.

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Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India This study is ongoing, but not recruiting participants.

Sponsor: AO Clinical Investigation and Documentation Information provided by (Responsible Party): AO Clinical Investigation and Documentation ClinicalTrials.gov Identifier: NCT01691599 First received: September 17, 2012 Last updated: March 18, 2014 Last verified: September 2012

Purpose The objectives of this study are to investigate infection rates and management for open and closed tibia fracture subjects in India treated with internal fixation. These objectives will be carried out by answering the following questions: 1. What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation?

2. What is the distribution of infection per type of infection, stratified by time (early, delayed, late) and location (superficial or deep) in open and closed tibia fracture subjects in India treated with internal fixation?

Secondary objectives 1. How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation?

2. What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation?

3. What is the influence of the following clinic and subject factors on the occurrence of infection within one year for open and closed tibia fracture subjects in India treated with internal fixation? a. Hospital standard hygienic and antibiotic protocol for infection prevention www.aocid.org

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b. Subject demographics c. Time between injury and surgery and between admission and surgery d. Fracture type (AO M端ller classification) e. Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures) f. Fracture management and implant type g. Surgical details such as duration of surgery 4. Is there a difference in health-related quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) between subjects with and without infections?

5. Is there a difference in the number of complications not related to infection (adverse events and serious adverse events) between subjects with and without infections?

Condition Tibia Fracture

Study Type:

Observational

Study Design:

Observational Model: Case-Only Time Perspective: Prospective

Official Title:

Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.

Resource links provided by NLM: MedlinePlus related topics: Fractures Leg Injuries and Disorders U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation: Primary Outcome Measures: www.aocid.org

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â&#x20AC;˘

Occurrence of infection [ Time Frame: From surgery until the date of first documented infection assessed up to 1 year ] [ Designated as safety issue: No ] LAB (CRP + ESR level, Leukocyte count / diff.) and bacteriology of wound swabs / aspirated liquids and sensitivity testing, if the patient is suspected for a surgical site infection (SSI) Secondary Outcome Measures:

â&#x20AC;˘

Change in Quality of life measurement (EQ-5D) [ Time Frame: Baseline and up to 5 day postoperative and 3months and 6months and 12 months ] [ Designated as safety issue: No ] Estimated Enrollment:

1000

Study Start Date:

August 2012

Estimated Study Completion Date:

June 2015

Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure) Groups/Cohorts Tibia fractures Patients with open and closed tibia fracture treated with internal fixation in India

Eligibility Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population Patients with open or closed tibia fractures

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Criteria Inclusion Criteria: 1. Men and women who are 18 years of age or older.

2. Open or closed tibia fracture treated by internal fixation (plate or nail), or by external fixation with planned conversion to plate or nail.

3. Ability to understand the content of the subject information / informed consent form and to be willing to participate in the clinical investigation.

4. Written informed consent. Subjects with bilateral fractures will be included. In these subjects, the most severe fracture will be the one included in the study.

Exclusion Criteria: 1. Previous wound infection or osteomyelitis at the same limb (according to subject history).

2. Subjects who plan to undergo conversion surgery at a different hospital.

3. Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.

4. Immunological deficiency disease.

5. Tumor related fractures.

6. Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5).

7. Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.

8. Subject is a prisoner.

9. Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study.

Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01691599.

Locations India Hi Tech Hospital Gandhinagar, Gujarat, India, 382006 www.aocid.org

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Dr. B.R. Ambedkar Medical College Hospital Bangalore, Karnataka, India, 560 045 MOSC Medical College Ernakulam District, Kerala, India, 625 007 Kolhapur Institute of Orthopedics and Trauma Kolhapur, Maharashtra, India, 416 001 Dr. Balabhai Nanavati Hospital Mumbai, Maharashtra, India, 400 056 Dr. R. N. Cooper Hospital Mumbai, Maharashtra, India, 400 056 Jai Hospital Pvt. Ltd. Nashik, Maharashtra, India, 422 002 Sancheti Hospital Pune, Maharashtra, India, 411005 Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan Sangli, Maharashtra, India, 416 416 Post Graduate Institute of Medical Education and Research Chandigarh, Punjab, India, 160 012 Mukhopadhaya Orthopaedic Clinic and Research Centre Bihar, India, 800 004

Sponsors and Collaborators AO Clinical Investigation and Documentation

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Investigators Principal Investigator:

Prakash J Doshi, MD

Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India

More Information No publications provided.

Responsible Party:

AO Clinical Investigation and Documentation

ClinicalTrials.gov Identifier: NCT01691599 Other Study ID Numbers:

INFINITI

Study First Received:

September 17, 2012

Last Updated:

March 18, 2014

Health Authority:

India: Health Ministry's Screening Committee (HMSC)

Keywords provided by AO Clinical Investigation and Documentation: Infection Open tibia fractures Closed tibia fractures Wound infection

Additional relevant MeSH terms: Communicable Diseases Fractures, Bone Infection

Tibial Fractures Leg Injuries Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2015.

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AOCID publications and presentations in 2014

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Scientific publications, posters and presentations in 2014 Peer-Reviewed Manuscripts

Published

Joeris A, Lutz N, Wicki B, Slongo T, Audige L. An epidemiological evaluation of pediatric long bone fractures — a retrospective cohort study of 2716 patients from two Swiss tertiary pediatric hospitals.

BMC Pediatrics. 2014;14:314.

Varga PP, Szövérfi Z, Fisher CG, Boriani S, Gokaslan ZL, Dekutoski MD, Chou D, Quraishi NA, Reynolds JJ, Luzzati A, Williams R, Fehlings MG, Germscheid NM, Lazary A, Rhines LD. Surgical treatment of sacral chordoma: prognostic variables for local recurrence and overall survival. Europ Spine J. 2014 Dec 23. [Epub ahead of print]

Cornelius CP, Kunz C, Neff A, Kellman RM, Prein J, Audigé L. The Comprehensive AOCMF Classification System: Fracture Case Collection, Diagnostic Imaging Work Up, AOCOIAC Iconography and Coding Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S131–S135

Prein J, Audigé L. The First Comprehensive AO Classification System for Fractures of the Craniomaxillofacial Skeleton.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S4–S5.

Cornelius CP, Audigé L, Kunz C, Prein J. The Comprehensive AOCMF Classification System: Glossary of Common Terminology.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S136–S140. www.aocid.org

176

Manson PN, Hollier L, Schubert W. CMF Classification.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S1–S3.

Buitrago-Téllez CH, Cornelius CP, Prein P, Kunz C, Di Ieva A, Audigé L. The Comprehensive AOCMF Classification System: Radiological Issues and Systematic Approach.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S123–S130.

Audigé L, Cornelius CP, Kunz C, Buitrago-Téllez CH, Prein J. The Comprehensive AOCMF Classification System: Classification and Documentation within AOCOIAC Software.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S114–S122.

Di Ieva A, Audigé L, Kellman RM, Shumrick KA, Ringl H, Prein J, Matula C. The Comprehensive AOCMF Classification: Skull Base and Cranial Vault Fractures – Level 2 and 3 Tutorial.

Craniomaxillofac Trauma Reconstruction 2014;7(Suppl 1):S103–S113.

Kunz C, Audigé L, Cornelius CP, Buitrago-Téllez CP, Rudderman R, Prein J. The Comprehensive AOCMF Classification System: Orbital Fractures - Level 3 Tutorial.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S92–S102.

Cornelius CP, Audigé L, Kunz C, Buitrago-Téllez CH, Rudderman R, Prein J. The Comprehensive AOCMF Classification System: Midface Fractures - Level 3 Tutorial.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S68–S91.

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Kunz C, Audigé L, Cornelius CP, Buitrago-Téllez CH, Frodel J, Rudderman R, Prein P. The Comprehensive AOCMF Classification System: Midface Fractures - Level 2 Tutorial.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S59–S67.

Neff A, Cornelius CP, Rasse M, Torre DD, Audigé L. The Comprehensive AOCMF Classification System: Condylar Process Fractures Level 3 Tutorial.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S44–S58.

Cornelius CP, Audigé L, Kunz C, Rudderman R, Buitrago-Téllez CH, Frodel J, Prein J. The Comprehensive AOCMF Classification System: Mandible Fractures-Level 3 Tutorial.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S31–S43.

Cornelius CP, Audigé L, Kunz C, Rudderman R, Buitrago-Téllez CH, Frodel J, Prein J. The Comprehensive AOCMF Classification System: Mandible Fractures- Level 2 Tutorial.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S15–S30

Audigé L, Cornelius CP, Di Ieva A, Prein J, CMF Classification Group.

The First AO Classification System for Fractures of the Craniomaxillofacial Skeleton: Rationale, Methodological Background, Developmental Process, and Objectives.

Craniomaxillofac Trauma Reconstruction. 2014;7(Suppl 1):S6–S14.

Höntzsch D, Schaser KD, Hofmann GO, Pohlemann T, Hem ES, Rothenbach E, Krettek C, Attal R. www.aocid.org

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Evaluation of the effectiveness of the angular stable locking system in patients with distal tibial fractures treated with intramedullary nailing: a multicenter randomized controlled trial.

J Bone Joint Surg Am. 2014 Nov 19;96(22):1889-97. doi: 10.2106/JBJS.M.01355.

Fisher CG, Versteeg A, Schouten R, Boriani S, Varga PP, Rhines LD, Heran MKS, Kawahara N, Fourney D, Reynolds JJ, Fehlings MG, Gokaslan ZL. Reliability of the Spinal Instability Neoplastic Score (SINS) among radiologists; an assessment of instability secondary to spinal metastases.

AJR Am J Roentgenol. 2014 Oct;203(4):869-74. doi: 10.2214/AJR.13.12269.

Fisher CG, Goldschlager T, Boriani S, Varga PP, Rhines LD, Fehlings MG, Luzzati A, Bilsky MH, Dekutoski MB, Reynolds JJ, Chou D, Berven S, Williams RP, Quraishi NA, Bettegowda C, Gokaslan ZL. An evidence based medicine model for rare and often neglected neoplastic conditions.

Journal of Neurosurgery: 2014 Nov;21(5):704-10. doi: 10.3171/2014.7.SPINE13954.

Epub 2014 Sep 5.

Garcia-Retamero R, Wicki B, Cokely E.T, Hanson B. Factors Predicting Surgeons' Preferred and Actual Roles in Interactions with Their Patients Health Psychology. 2014 Aug;33(8):920-8. doi: 10.1037/hea0000061. Epub 2014 Feb 10.

Sawaguchi T, Sakagoshi D, Yosuke S, Takaaki I, Goldhahn S. Do design adaptations of a trochanteric nail make sense for Asian patients? Results of a multicenter study of the PFNA-II in Japan Injury. 2014 Jun 10. pii: S0020-1383(14)00280-0. doi: 10.1016/j.injury.2014.06.002.

[Epub ahead of print]

Boriani S, Lo SL, Puvanesarajah V, Fisher CG, Varga PP, Rhines LD, Germscheid www.aocid.org

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NM, Luzzati A, Chou D, Reynolds JJ, Williams RP, Zadnik P, Groves M, Sciubba DM, Bettegowda C, Gokaslan ZL. AOSpine Knowledge Forum Tumor. Aneurysmal bone cysts of the spine: treatment options and considerations.

J Neurooncol. 2014 Oct;120(1):171-8. doi: 10.1007/s11060-014-1540-0. Epub 2014 Jul 25.

Kralinger F, Blauth M, Goldhahn J, Kaech K, Voigt Ch, Platz A, Hanson B. The Influence of Local Bone Density on the Outcome of one hundred and fifty Proximal Humeral Fractures Treated with a Locking Plate.

Journal of Bone and Joint Surgery [Am]. 2014 Jun 18;96(12):1026-1032. [Epub ahead of print]

Matityahu A, Kahler D, Krettek C, Stรถckle U, Grutzner PA, Messmer P, Ljungqvist J, Gebhard F. Three-dimensional navigation is more accurate than two-dimensional navigation or conventional fluoroscopy for percutaneous sacroiliac screw fixation in the dysmorphic sacrum: a randomized multicenter study.

J Orthop Trauma. 2014 Dec;28(12):707-10. doi: 10.1097/BOT.0000000000000092.

Fisher CG, Schouten R, Versteeg AL, Boriani S, Varga PP, Rhines LD, Kawahara N, Fourney D, Weir L, Reynolds JJ, Sahgal A, Fehlings MG, Gokaslan ZL. Reliability of the Spinal Instability Neoplastic Score (SINS) among radiation oncologists; an assessment of instability secondary to spinal metastases.

Radiation Oncology. 2014 Mar 4;9:69. doi: 10.1186/1748-717X-9-69.

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Accepted

Sciubba DM, Macki M, Bydon M, Germscheid NM, Wolinsky JP, Boriani S, Bettegowda C, Chou D, Luzzati A, Reynolds JJ, Szövérfi Z, Zadnik P, Rhines LD, Gokaslan ZL, Fisher CG, Varga PP. Long-term outcomes in primary, spinal osteochondroma: a multicenter study of 27 patients.

Spine (Accepted, October 2014).

Kepler CK, Vaccaro AR, Koerner JD, Dvorak M, Kandziora F, Rajasekaran S, Aarabi B, Vialle L, Fehlings MG, Schroeder GD, Reinhold M, Schnake KJ, Bellabarba C, Oner FC. Reliability Analysis of the AOSpine thoracolumbar Spine Injury Classification System

by Worldwide Group of Naïve Spinal Surgeons.

Spine

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Non Peer-Reviewed Manuscripts

Hanson B, De Faoite D. Sugestoes praticas sobre como realizar um estudo clinico Educacao em pesquisa AOSpine Latin America: Da ideia a publicacao/org. Astrubal Falavigna, José Maria Jiménez Avila—Caxias do Sul, RS: Educs, 2014. 322 p.: il; 23 cm. ISBN 978-85-7061-736-1

De Faoite D. Getting more out of PowerPoint® Medical Writing, 2014; 23(1):22-24

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Podium Presentations

Deutscher Kongress für Orthopädie und Unfallchirurgie (DKOU), Berlin, Germany, October 28-31, 2014 R. Attal, K.D. Schaser, D. Höntzsch Untersuchung der klinischen Wirksamkeit der winkelstabilen Verriegelung in der intramedullären Nagelung bei Patienten mit distalen Tibiafrakturen: eine multizentrische, randomisiert-kontrollierte Studie (Presentation with evidence based medicine commentary)

Hanson B, De Faoite D. The use of checklists in surgery: a paper tiger or a cost-effective life-saving device?

D. Höntzsch, B. Hanson, D. De Faoite Mixing different types of metallic implants during fracture fixation – results of an online survey of over 1,000 surgeons

2014 Scoliosis Research Society (SRS) Meeting. Anchorage, Alaska. September 1013, 2014.

Fehlings M, Lenke L, Shaffrey Ch, Kopjar B, MC Cheung K, Carreon L, Dekutoski M, Schwab F, Boachie-Adjei O, Kebaish K, Ames Ch, Qiu Y, Matsuyama Y, Dahl B, Mehdian H, Pellisé-Urquiza F, Lewis S, Berven S. Risk Factors for Neurological Complications in Patients Undergoing Corrective Surgery for Spinal Deformity: Results of the Scoli-Risk 1 Study International, Prospective, Multicentre Study.

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS), Jahrestagung, September 7-10, 2014 Hanson B, De Faoite D. Multicultural barriers to data collection: The use of outcome measurements in internationally conducted research.

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3rd Annual Global Healthcare Conference, Singapore, June 23-24, 2014 Hanson B, De Faoite D. Multicultural challenges in conducting multicenter trials

European Federation of Orthopaedics and Traumatology (EFORT) Congress, London, UK, 4-6 June 2014 De Boer P. Proximal III or IV Part Humerus Fractures: Conservative.

87th Annual meeting of the Japanese Orthopedic Association, Kobe,Japan, May 2014 Nakamura N, Sawaguchi T, Takeuchi R, Goldhahn S. Cross-cultural adaptation and validation of the knee injury and osteoarthritis outcome score (KOOS) for Japanese-speaking patients.

101. Jahreskongress der Schweizerischen Gesellschaft f체r Chirurgie, Bern, Switzerland, May 21-23, 2014 Hanson B, De Faoite D. The use of checklists in surgery: a paper tiger or a cost-effective life-saving device?

International Society for Fracture Repair (ISFR), 14th Biennial Conference, New York, USA, May 14-17, 2014 Goldhahn S, K채ch K, Platz A, Ljungqvist J, Perry P. The Lower Extremity Measure for hip fracture patients- added value or added burden?

Kathrein S, Joeris A, Kralinger F, Goldhahn J. Significant differences between local reporting and central assessment of radiological complications in a prospective, multicenter study about locking plate fixation of proximal

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American Association of Neurological Surgeons (AANS) Annual Meeting. San Francisco, CA. April 5-9, 2014.

M.G. Fehlings, L. G. Lenke, Ch. I. Shaffrey, K. MC Cheung, L. Carreon, M. B. Dekutoski, F. J. Schwab, O. Boachie-Adjei, K. M. Kebaish, Ch. P. Ames, Y. Qiu, Y. Matsuyama, B. T. Dahl, H. Mehdian, F. PellisĂŠ-Urquiza, S. J. Lewis, S. H. Berven Prospective, Multicenter Assessment of Acute Neurologic Complications following Complex Adult Spinal Deformity Surgery: The Scoli-RISK-1 Study

Orthopaedic Research Society, 60th Anniversary, New Orleans, Lousiana, March 1518, 2014 Elsley M. Funding Mechanisms for Clinical Research.

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Posters

Society for Risk Analysis Annual Meeting 2014, Denver, Colorado. December 7-10, 2014.

Garcia-Retamero R, Wicki B, Hanson B. Factors Predicting Surgeonsâ&#x20AC;&#x2122; Preferred and Actual Roles in Interactions with Their Patients.

Annual Meeting of the Society for Judgment and Decision Making (SJDM). Long Beach, California. November 21-24, 2014.

Garcia-Retamero R, Cokely E, Wicki B, Hanson B. Factors Influencing Surgeonsâ&#x20AC;&#x2122; Roles in Interactions with Their Patients.

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AOCID abstracts of peer-reviewed publications in 2014

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BMC Pediatr. 2014 Dec 20;14(1):314.

An epidemiological evaluation of pediatric long bone fractures - a retrospective cohort study of 2716 patients from two Swiss tertiary pediatric hospitals.

Joeris A, Lutz N, Wicki B, Slongo T, Audigé L. BACKGROUND: Children and adolescents are at high risk of sustaining fractures during growth.

Therefore, epidemiological assessment is crucial for fracture prevention. The AO Comprehensive Injury Automatic Classifier (AO COIAC) was used to evaluate epidemiological data of pediatric long bone fractures in a large cohort.

METHODS: Data from children and adolescents with long bone fractures sustained between 2009 and 2011, treated at either of two tertiary pediatric surgery hospitals in Switzerland, were retrospectively collected. Fractures were classified according to the AO Pediatric Comprehensive Classification of Long Bone Fractures (PCCF).

RESULTS: For a total of 2716 patients (60% boys), 2807 accidents with 2840 long bone fractures (59% radius/ulna; 21% humerus; 15% tibia/fibula; 5% femur) were documented. Children's mean age (SD) was 8.2 (4.0) years (6% infants; 26% preschool children; 40% school children; 28% adolescents). Adolescent boys sustained more fractures than girls (p < 0.001). The leading cause of fractures was falls (27%), followed by accidents occurring during leisure activities (25%), at home (14%), on playgrounds (11%), and traffic (11%) and school accidents (8%). There was boy predominance for all accident types except for playground and at home accidents. The distribution of accident types differed according to age classes (p < 0.001). Twenty-six percent of patients were classed as overweight or obese higher than data published by the WHO for the corresponding ages - with a higher proportion of overweight and obese boys than in the Swiss population (p < 0.0001).

CONCLUSION: Overall, differences in the fracture distribution were sex and age related. Overweight and obese patients seemed to be at increased risk of sustaining fractures. Our data give valuable input into future development of prevention strategies. The AO PCCF proved to be useful in epidemiological reporting and analysis of pediatric long bone fractures.

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Eur Spine J. 2014 Dec 23. [Epub ahead of print] Surgical treatment of sacral chordoma: prognostic variables for local recurrence and overall survival.

Varga PP1, Szövérfi Z, Fisher CG, Boriani S, Gokaslan ZL, Dekutoski MB, Chou D, Quraishi NA, Reynolds JJ, Luzzati A, Williams R, Fehlings MG, Germscheid NM, Lazary A, Rhines LD.

PURPOSE: Sacral chordomas (SC) are rare, locally invasive, malignant neoplasms. Despite surgical resection and adjuvant therapies, local recurrence (LR) is common and overall survival (OS) is poor. The objective of this study was to identify prognostic factors that have an impact on the local recurrence-free survival (LRFS) and OS of patients with SC. METHODS: Utilizing the AOSpine Knowledge Forum Tumor multicenter ambispective database, surgically treated SC cases were identified. Cox regression modeling was used to assess the effect of several clinically relevant variables on OS and LRFS. RESULTS: A total of 167 patients with surgically treated SC were identified. The male/female ratio was 98/69 with a mean age of 57 ± 15 years at the time of surgery. The LR was 35 % (n = 57), death occurred in 30 % of patients (n = 50) during the study period.

The median OS was 6 years post-surgery and LRFS was 4 years. In the univariate analysis, previous tumor surgery at the same site (P = 0.002), intralesional resection (P < 0.001), and larger tumor volume (P = 0.030) were significantly associated with LR. Increasing age (P < 0.001) and a preoperative motor deficit of C or D (P = 0.003) were significantly associated with poor OS, and nerve root sacrifice showed a trend towards significance (P = 0.088). In the multivariate models, previous surgery and intralesional resection were significantly related to LR, while increasing age and motor deficit of C or D were associated with poor OS. CONCLUSIONS: This study identified two predictive variables for LRFS (previous tumor surgery and type of surgical resection) and two for OS (age and impaired motor function) in surgically treated SC patients. Our results indicate that en bloc resection reduces LR but does not influence OS. However, this was likely due to short follow-up (3.2 years).

PMID: 25533857 [PubMed - as supplied by publisher]

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S131-5. doi: 10.1055/s0034-1393722.

The Comprehensive AOCMF Classification System: Fracture Case Collection, Diagnostic Imaging Work Up, AOCOIAC Iconography and Coding.

Cornelius CP1, Kunz C2, Neff A3, Kellman RM4, Prein J2, AudigĂŠ L5.

The AO classification system for fractures in the adult craniomaxillofacial (CMF) skeleton is organized in anatomic modules in a 3 precision-level hierarchy with account for an increasing complexity and details. Level-1 is most elementary and identifies no more than the presence of fractures in 4 separate anatomical units: the mandible (code 91), midface (92), skull base (93) and cranial vault (94). Level-2 relates the detailed topographic location of the fractures within defined regions of the mandible, central and lateral midface, internal orbit, endo- and exocranial skull base, and the cranial vault. Level-3 is based on an even more refined topographic assessment and focuses on the morphology - fragmentation, displacement, and bone defects - within specified subregions. An electronic fracture case collection complements the preceding tutorial papers, which explain the features and options of the AOCMF classification system in this issue of the Journal. The electronic case collection demonstrates a range of representative osseous CMF injuries on the basis of diagnostic images, narrative descriptions of the fracture diagnosis and their classification using the icons for illustration and coding of a dedicated software AOCOIAC (AO Comprehensive Injury Automatic Classifier). Ninety four case examples are listed in two tables for a fast overview of the electronic content. Each case can serve as a guide to getting started with the new AOCMF classification system using AOCOIAC software and to employ it in the own clinical practice.

KEYWORDS: case collection; classification system; clinical documentation system; craniomaxillofacial fractures PMID: 25489397 [PubMed] PMCID: PMC4251729

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S123-30. doi: 10.1055/s0034-1389565.

The Comprehensive AOCMF Classification System: Radiological Issues and Systematic Approach.

Buitrago-TĂŠllez CH1, Cornelius CP2, Prein J3, Kunz C3, di Ieva A4, AudigĂŠ L5.

The AOCMF Classification Group developed a hierarchical three-level craniomaxillofacial (CMF) classification system with increasing level of complexity and details. The basic level 1 system differentiates fracture location in the mandible (code 91), midface (code 92), skull base (code 93), and cranial vault (code 94); the levels 2 and 3 focus on defining fracture location and morphology within more detailed regions and subregions. Correct imaging acquisition, systematic analysis, and interpretation according to the anatomic and surgical relevant structures in the CMF regions are essential for an accurate, reproducible, and comprehensive diagnosis of CMF fractures using that system. Basic principles for radiographic diagnosis are based on conventional plain films, multidetector computed tomography, and magnetic resonance imaging. In this tutorial, the radiological issues according to each level of the classification are described.

KEYWORDS: computer tomography (CT); craniomaxillofacial, fractures; diagnostic process; imaging PMID: 25489396 [PubMed] PMCID: PMC4251726

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S114-22. doi: 10.1055/s0034-1389564.

The Comprehensive AOCMF Classification System: Classification and Documentation within AOCOIAC Software.

AudigĂŠ L1, Cornelius CP2, Kunz C3, Buitrago-TĂŠllez CH4, Prein J3.

The AOCMF Classification Group developed a hierarchical three-level craniomaxillofacial (CMF) fracture classification system. The fundamental level 1 distinguishes four major anatomical units including the mandible (code 91), midface (code 92), skull base (code 93) and cranial vault (code 94); level 2 relates to the location of the fractures within defined topographical regions within each units; level 3 relates to fracture morphology in these regions regarding fragmentation, displacement, and bone defects, as well as the involvement of specific anatomical structures. The resulting CMF classification system has been implemented into AO comprehensive injury automatic classifier (AOCOIAC) software allowing for fracture classification as well as clinical documentation of individual cases including a selected sample of diagnostic images. This tutorial highlights the main features of the software. In addition, a series of illustrative case examples is made available electronically for viewing and editing.

KEYWORDS: classification system; coding; craniomaxillofacial fractures; electronic documentation system PMID: 25489395 [PubMed] PMCID: PMC4251723

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S015-30. doi: 10.1055/s0034-1389557.

The Comprehensive AOCMF Classification System: Mandible Fractures- Level 2 Tutorial.

Cornelius CP1, AudigĂŠ L2, Kunz C3, Rudderman R4, Buitrago-TĂŠllez CH5, Frodel J6, Prein J3.

This tutorial outlines the details of the AOCMF image-based classification system for fractures of the mandible at the precision level 2 allowing description of their topographical distribution. A short introduction about the anatomy is made.

Mandibular fractures are classified by the anatomic regions involved. For this purpose, the mandible is delineated into an array of nine regions identified by letters: the symphysis/parasymphysis region anteriorly, two body regions on each lateral side, combined angle and ascending ramus regions, and finally the condylar and coronoid processes. A precise definition of the demarcation lines between these regions is given for the unambiguous allocation of fractures. Four transition zones allow an accurate topographic assignment if fractures end up in or run across the borders of anatomic regions. These zones are defined between angle/ramus and body, and between body and symphysis/parasymphysis. A fracture is classified as "confined" as long as it is located within a region, in contrast to a fracture being "nonconfined" when it extents to an adjoining region. Illustrations and case examples of mandible fractures are presented to become familiar with the classification procedure in daily routine.

KEYWORDS: anatomic regions; confined fractures; fracture classification; mandible; transition zones PMID: 25489388 [PubMed] PMCID: PMC4251718

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S031-43. doi: 10.1055/s0034-1389558.

The Comprehensive AOCMF Classification System: Mandible Fractures-Level 3 Tutorial.

Cornelius CP1, AudigĂŠ L2, Kunz C3, Rudderman R4, Buitrago-TĂŠllez CH5, Frodel J6, Prein J3.

This tutorial outlines the details of the AOCMF image-based classification system for fractures of the mandibular arch (i.e. the non-condylar mandible) at the precision level 3. It is the logical expansion of the fracture allocation to topographic mandibular sites outlined in level 2, and is based on three-dimensional (3D) imaging techniques/computed tomography (CT)/cone beam CT). Level 3 allows an anatomical description of the individual conditions of the mandibular arch such as the preinjury dental state and the degree of alveolar atrophy. Trauma sequelae are then addressed: (1) tooth injuries and periodontal trauma, (2) fracture involvement of the alveolar process, (3) the degree of fracture fragmentation in three categories (none, minor, and major), and (4) the presence of bone loss. The grading of fragmentation needs a 3D evaluation of the fracture area, allowing visualization of the outer and inner mandibular cortices. To document these fracture features beyond topography the alphanumeric codes are supplied with distinctive appendices. This level 3 tutorial is accompanied by a brief survey of the peculiarities of the edentulous atrophic mandible. Illustrations and a few case examples serve as instruction and reference to improve the understanding and application of the presented features.

KEYWORDS: degrees of alveolar atrophy; dentition; fracture classification; fracture morphology; mandible PMID: 25489389 [PubMed] PMCID: PMC4251719

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S092-102. doi: 10.1055/s0034-1389562.

The Comprehensive AOCMF Classification System: Orbital Fractures - Level 3 Tutorial.

Kunz C1, AudigĂŠ L2, Cornelius CP3, Buitrago-TĂŠllez CH4, Rudderman R5, Prein J3.

The AOCMF Classification Group developed a hierarchical three-level craniomaxillofacial classification system with increasing level of complexity and details. Within the midface (level 1 code 92), the level 2 system describes the location of the fractures within defined regions in the central and lateral midface including the internal orbit. This tutorial outlines the level 3 detailed classification system for fractures of the orbit. It depicts the orbital fractures according to the subregions defined as orbital rims, anterior orbital walls, midorbit, and apex. The system allows documentation of the involvement of specific orbital structures such as inferior orbital fissure, internal orbital buttress, the greater wing of sphenoid, lacrimal bone, superior orbital fissure, and optic canal. The classification system is presented along with rules for fracture location and coding, a series of case examples with clinical imaging and a general discussion on the design of this classification.

KEYWORDS: anatomic regions; fracture classification; midface; orbit PMID: 25489393 [PubMed] PMCID: PMC4251722

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S103-13. doi: 10.1055/s0034-1389563.

The Comprehensive AOCMF Classification: Skull Base and Cranial Vault Fractures - Level 2 and 3 Tutorial.

Di Ieva A1, AudigĂŠ L2, Kellman RM3, Shumrick KA4, Ringl H5, Prein J6, Matula C7.

The AOCMF Classification Group developed a hierarchical three-level craniomaxillofacial classification system with increasing level of complexity and details. The highest level 1 system distinguish four major anatomical units, including the mandible (code 91), midface (code 92), skull base (code 93), and cranial vault (code 94). This tutorial presents the level 2 and more detailed level 3 systems for the skull base and cranial vault units. The level 2 system describes fracture location outlining the topographic boundaries of the anatomic regions, considering in particular the endocranial and exocranial skull base surfaces. The endocranial skull base is divided into nine regions; a central skull base adjoining a left and right side are divided into the anterior, middle, and posterior skull base. The exocranial skull base surface and cranial vault are divided in regions defined by the names of the bones involved: frontal, parietal, temporal, sphenoid, and occipital bones. The level 3 system allows assessing fracture morphology described by the presence of fracture fragmentation, displacement, and bone loss. A documentation of associated intracranial diagnostic features is proposed. This tutorial is organized in a sequence of sections dealing with the description of the classification system with illustrations of the topographical skull base and cranial vault regions along with rules for fracture location and coding, a series of case examples with clinical imaging and a general discussion on the design of this classification.

KEYWORDS: classification system; cranial vault; fracture classification; skull base PMID: 25489394 [PubMed] PMCID: PMC4251721

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S044-58. doi: 10.1055/s0034-1389559.

The Comprehensive AOCMF Classification System: Condylar Process Fractures - Level 3 Tutorial.

Neff A1, Cornelius CP2, Rasse M3, Torre DD3, AudigĂŠ L4.

This tutorial outlines the detailed system for fractures of the condylar process at the precision level 3 and is organized in a sequence of sections dealing with the description of the classification system within topographical subdivisions along with rules for fracture coding and a series of case examples with clinical imaging.

Basically, the condylar process comprises three fracture levels and is subdivided into the head region, the condylar neck, and the condylar base. Fractures of the condylar head show typical fracture lines either within the lateral pole zone, which may lead to loss of vertical height, or medially to the pole zone, with the latter ones usually not compromising the vertical condyle to fossa relation. In condylar head fractures, the morphology is further described by the presence of minor or major fragmentation, the vertical apposition of fragments at the plane of the head fracture, the displacement of the condylar head with regard to the fossa including a potential distortion of the condylar head congruency resulting in dystopic condyle to fossa relations and the presence or absence of a loss of vertical ramus height. A specific vertical fracture pattern extending from the head to the neck or base subregion is considered.

Fractures of the condylar neck and base can be differentiated according to a newly introduced one-third to two-thirds rule with regard to the proportion of the fracture line above and below the level of the sigmoid notch, which is presented in the classification article, and are basically subdivided according to the presence or absence of displacement or dislocation. In both condylar neck and base fractures, the classification is again based on the above mentioned parameters such as fragmentation, displacement of the condylar head with regard to the fossa, including dystopic condyle to fossa relations and loss of vertical ramus height, that is, according to the measurement of the condylar process. In addition, the classification assesses a sideward displacement including the respective displacement sector at the neck or base fracture site as well as the angulation of the superior main fragment and also considers a potential displacement of the caudal fragment with regard to the fossa, which may occur in fractures affecting additional fracture locations in the mandible. The design of this classification is discussed along with a review of existing classification systems. The condylar process for fracture location was defined according to the level 2 system presented in a previous tutorial in this special issue.

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KEYWORDS: classification condylar process; condylar base; condylar head; condylar neck PMID: 25489390 [PubMed] PMCID: PMC4251730

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S059-67. doi: 10.1055/s0034-1389560.

The Comprehensive AOCMF Classification System: Midface Fractures - Level 2 Tutorial.

Kunz C1, AudigĂŠ L2, Cornelius CP3, Buitrago-TĂŠllez CH4, Frodel J5, Rudderman R6, Prein J3.

The AOCMF Classification Group developed a hierarchical three-level craniomaxillofacial classification system with increasing level of complexity and details. The highest level 1 system distinguish four major anatomical units including the mandible (code 91), midface (code 92), skull base (code 93), and cranial vault (code 94). This tutorial presents the level 2 system for the midface unit that concentrates on the location of the fractures within defined regions in the central (upper, intermediate, and lower) and lateral (zygoma, pterygoid) midface, as well as the internal orbit and palate. The level 2 midface fracture location outlines the topographic boundaries of the anatomical regions. The common nasoorbitoethmoidal and zygoma en bloc fracture patterns, as well as the time-honored Le Fort classification are taken into account. This tutorial is organized in a sequence of sections dealing with the description of the classification system with illustrations of the topographical cranial midface regions along with rules for fracture location and coding, a series of case examples with clinical imaging and a general discussion on the design of this classification. Individual fracture mapping in these regions regarding severity, fragmentation, displacement of the fragment or bone defect is addressed in a more detailed level 3 system in the subsequent articles.

KEYWORDS: anatomic regions; fracture classification; midface PMID: 25489391 [PubMed] PMCID: PMC4251720

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S068-91. doi: 10.1055/s0034-1389561.

The Comprehensive AOCMF Classification System: Midface Fractures - Level 3 Tutorial.

Cornelius CP1, AudigĂŠ L2, Kunz C3, Buitrago-TĂŠllez CH4, Rudderman R5, Prein J3.

This tutorial outlines the details of the AOCMF image-based classification system for fractures of the midface at the precision level 3. The topography of the different midface regions (central midface-upper central midface, intermediate central midface, lower central midface-incorporating the naso-orbito-ethmoid region; lateral midfacezygoma and zygomatic arch, palate) is subdivided in much greater detail than in level 2 going beyond the Le Fort fracture types and its analogs. The level 3 midface classification system is presented along with guidelines to precisely delineate the fracture patterns in these specific subregions. It is easy to plot common fracture entities, such as nasal and naso-orbito-ethmoid, and their variants due to the refined structural layout of the subregions. As a key attribute, this focused approach permits to document the occurrence of fragmentation (i.e., single vs. multiple fracture lines), displacement, and bone loss. Moreover, the preinjury dental state and the degree of alveolar atrophy in edentulous maxillary regions can be recorded. On the basis of these individual features, tooth injuries, periodontal trauma, and fracture involvement of the alveolar process can be assessed. Coding rules are given to set up a distinctive formula for typical midface fractures and their combinations. The instructions and illustrations are elucidated by a series of radiographic imaging examples. A critical appraisal of the design of this level 3 midface classification is made.

KEYWORDS: central and lateral midface; fracture classification; tooth injuries; zygoma PMID: 25489392 [PubMed] PMCID: PMC4251725

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Craniomaxillofac Trauma Reconstr. 2014 Dec;7(Suppl 1):S006-14. doi: 10.1055/s0034-1389556.

The First AO Classification System for Fractures of the Craniomaxillofacial Skeleton: Rationale, Methodological Background, Developmental Process, and Objectives.

AudigĂŠ L1, Cornelius CP2, Di Ieva A3, Prein J4; CMF Classification Group 6.

Validated trauma classification systems are the sole means to provide the basis for reliable documentation and evaluation of patient care, which will open the gateway to evidence-based procedures and healthcare in the coming years. With the support of AO Investigation and Documentation, a classification group was established to develop and evaluate a comprehensive classification system for craniomaxillofacial (CMF) fractures. Blueprints for fracture classification in the major constituents of the human skull were drafted and then evaluated by a multispecialty group of experienced CMF surgeons and a radiologist in a structured process during iterative agreement sessions. At each session, surgeons independently classified the radiological imaging of up to 150 consecutive cases with CMF fractures. During subsequent review meetings, all discrepancies in the classification outcome were critically appraised for clarification and improvement until consensus was reached.

The resulting CMF classification system is structured in a hierarchical fashion with three levels of increasing complexity. The most elementary level 1 simply distinguishes four fracture locations within the skull: mandible (code 91), midface (code 92), skull base (code 93), and cranial vault (code 94). Levels 2 and 3 focus on further defining the fracture locations and for fracture morphology, achieving an almost individual mapping of the fracture pattern. This introductory article describes the rationale for the comprehensive AO CMF classification system, discusses the methodological framework, and provides insight into the experiences and interactions during the evaluation process within the core groups. The details of this system in terms of anatomy and levels are presented in a series of focused tutorials illustrated with case examples in this special issue of the Journal.

KEYWORDS: classification system; craniomaxillofacial; diagnostic process; fracture; reliability PMID: 25489387 [PubMed] PMCID: PMC4251717

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J Bone Joint Surg Am. 2014 Nov 19;96(22):1889-97. doi: 10.2106/JBJS.M.01355.

Evaluation of the effectiveness of the angular stable locking system in patients with distal tibial fractures treated with intramedullary nailing: a multicenter randomized controlled trial.

HĂśntzsch D1, Schaser KD2, Hofmann GO3, Pohlemann T4, Hem ES5, Rothenbach E6, Krettek C7, Attal R8.

BACKGROUND: Angular stable locking of intramedullary nails has been shown to enhance fixation stability of tibial fractures in biomechanical and animal studies. The aim of our study was to assess whether use of the angular stable locking system or conventional locking resulted in earlier full weight-bearing with minimum pain for patients with a distal tibial fracture treated with an intramedullary nail.

METHODS: A prospective multicenter, randomized, patient-blinded trial was conducted with adults who had a distal tibial fracture. Patients' fractures were managed with an intramedullary nail locked with either an angular stable locking system or conventional locking screws. Outcomes were evaluated at six weeks, twelve weeks, six months, and one year after surgery. Time to full weight-bearing with minimum pain was calculated with use of daily entries from patient diaries. Secondary outcomes included pain at the fracture site under load, quality of life, gait analysis, mobility, radiographic findings, and adverse events.

RESULTS: One hundred and forty-two patients were randomly allocated to two treatment groups: seventy-five to the group receiving intramedullary nailing with the angular stable locking system and sixty-seven to the group receiving conventional intramedullary nailing. No clinically important differences were found for either the primary or secondary outcome parameters between the groups during the entire follow-up period.

CONCLUSIONS: Use of an angular stable locking system with intramedullary nailing did not improve the outcome compared with conventional locking screws in the treatment of distal tibial fractures.

Copyright Š 2014 by The Journal of Bone and Joint Surgery, Incorporated.

PMID: 25410507 www.aocid.org

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AJR Am J Roentgenol. 2014 Oct;203(4):869-74. doi: 10.2214/AJR.13.12269.

Reliability of the spinal instability neoplastic scale among radiologists: an assessment of instability secondary to spinal metastases.

Fisher CG1, Versteeg AL, Schouten R, Boriani S, Varga PP, Rhines LD, Heran MK, Kawahara N, Fourney D, Reynolds JJ, Fehlings MG, Gokaslan ZL.

OBJECTIVE: The spinal instability neoplastic scale (SINS) is a new classification system for tumorrelated spinal instability. The SINS may prove to be a valuable tool for radiologists to communicate with oncologists and surgeons in a standardized evidence-based manner. The objective of this study was to determine the inter- and intraobserver reliability and validity of the SINS among radiologists.

MATERIALS AND METHODS: Thirty-seven radiologists from 10 international sites used the SINS to categorize the degree of spinal instability in 30 patients with spinal tumors. To assess validity, we compared the SINS scores assigned by the radiologists with the SINS scores of 11 spine oncology surgeons (reference standard). Each total SINS score (range, 0-18 points) was converted into one of the following three clinical categories: 0-6 points, stable; 7-12 points, potentially unstable; and 13-18 points, unstable. In addition, each total SINS score was converted into a binary scale: 0-6 points was defined as stable, and 7-18 points was considered a current or possible instability for which surgical consultation is recommended.

RESULTS: Radiologists using the SINS binary scale showed excellent (κ = 0.88) validity, substantial (κ = 0.76) interobserver agreement, and excellent (κ = 0.82) intraobserver reproducibility. Radiologists rated all unstable cases and 621 of 629 (98.7%) potentially unstable cases with a SINS score of 7 or more points, thus appropriately initiating a referral for surgical assessment.

CONCLUSION: SINS is a reliable tool for radiologists rating tumor-related spinal instability. It accurately discriminates between stable and potentially unstable or unstable lesions and, therefore, can guide the need for surgical consultation.

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KEYWORDS: metastasis; neoplasm; radiologist reliability; spinal instability; spinal instability neoplastic scale (SINS); spine; validity PMID: 25247954

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J Neurosurg Spine. 2014 Nov;21(5):704-10. doi: 10.3171/2014.7.SPINE13954. Epub 2014 Sep 5.

An evidence-based medicine model for rare and often neglected neoplastic conditions.

Fisher CG1, Goldschlager T, Boriani S, Varga PP, Rhines LD, Fehlings MG, Luzzati A, Dekutoski MB, Reynolds JJ, Chou D, Berven SH, Williams RP, Quraishi NA, Bettegowda C, Gokaslan ZL.

OBJECT: The National Institutes of Health recommends strategies to obtain evidence for the treatment of rare conditions such as primary tumors of the spine (PTSs). These tumors have a low incidence and are pathologically heterogeneous, and treatment approaches are diverse. Appropriate evidence-based care is imperative. Failure to follow validated oncological principles may lead to unnecessary mortality and profound morbidity. This paper outlines a scientific model that provides significant evidence guiding the treatment of PTSs. METHODS: A four-stage approach was used: 1) planning: data from large-volume centers were reviewed to provide insight; 2) recruitment: centers were enrolled and provided the necessary infrastructure; 3) retrospective stage: existing medical records were reviewed and completed with survival data; and 4) prospective stage: prospective data collection has been implemented. The AOSpine Knowledge Forum Tumor designed six modules: demographic, clinical, diagnostic, therapeutic, local recurrence, survival, and perioperative morbidity data fields and provided funding.

RESULTS: It took 18 months to implement Stages 1-3, while Stage 4 is ongoing. A total of 1495 tumor cases were captured and diagnosed as one of 18 PTS histotypes. In addition, a PTS biobank network has been created to link clinical data with tumor pathology and molecular analysis.

CONCLUSIONS: This scientific model has not only aggregated a large amount of PTS data, but has also established an international collaborative network of spine oncology centers.

Access to large volumes of data will generate further research to guide and enhance PTS clinical management. This model could be applied to other rare neoplastic conditions. Clinical trial registration no.: NCT01643174 (ClinicalTrials.gov).

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KEYWORDS: AOSKFT = AOSpine International Knowledge Forum Tumor; FFPE = formalin-fixed paraffin embedded; NIH = National Institutes of Health; PTS = primary tumor of the spine; WBB = Weinstein-Boriani-Biagini; network; oncology; primary tumor; rare disease; scientific model; spine; surgery

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Health Psychol. 2014 Aug;33(8):920-8. doi: 10.1037/hea0000061. Epub 2014 Feb 10.

Factors predicting surgeons' preferred and actual roles in interactions with their patients.

Garcia-Retamero R1, Wicki B2, Cokely ET3, Hanson B2.

BACKGROUND: Although shared decision making offers clinical benefits, there is a lack of research investigating physicians' roles in interactions with their patients. Research examining what characterizes physicians who involve patients in decision making is also limited.

The authors investigated surgeons' preferred and usual roles in interactions with patients, and whether these roles are influenced by their gender, experience, area of expertise, numeracy, and cultural background.

METHODS AND RESULTS: Participants were a diverse sample of 292 surgeons from 60 countries. Surgeons completed a survey about their usual and preferred roles in medical decision making.

They also completed the Berlin Numeracy Test-a brief instrument designed to measure numeracy in culturally diverse educated individuals. Most surgeons preferred to share decision making with patients, but very few reported having a collaborative role in typical interactions. Female surgeons showed a stronger preference for collaborative decision making than their male counterparts (OR = 2.08). However, female surgeons more often played an active role in medical decision making, involving patients less often (OR = 5.39). Surgeons with low numeracy (OR = 3.83), less experienced surgeons (OR = 3.15), and surgeons from individualistic countries (OR = 1.82) rarely involved patients in decision making.

CONCLUSIONS: Most surgeons reported that shared decision making was their preferred method for medical decision making. Unfortunately, many of them were insufficiently equipped to take a more collaborative role in interactions with patients. Gender, numeracy, length of experience, and cultural background limited their willingness to collaborate. Future research should identify effective interventions that help overcome barriers to shared decision making.

PMID: 24512324

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Injury. 2014 Oct;45(10):1624-31. doi: 10.1016/j.injury.2014.06.002. Epub 2014 Jun 10.

Do design adaptations of a trochanteric nail make sense for Asian patients?

Results of a multicenter study of the PFNA-II in Japan.

Sawaguchi T1, Sakagoshi D2, Shima Y3, Ito T4, Goldhahn S5.

PURPOSE: Asian patients with osteoporosis suffer from an increased incidence of hip fracture and a potentially increased risk of fixation failure due to anatomical differences compared to Caucasians. To cope with these differences, an Asian size- and geometry-adapted Proximal Femoral Nail Antirotation (PFNA-II) was developed. The objective of this prospective multicenter study was to assess the risk of fracture fixation complications (FFCs), the occurrence of mismatch and the quality of life status of patients treated with the PFNA-II. PATIENTS AND METHODS: 176 Japanese patients with an isolated, unstable, closed trochanteric fracture were treated with the PFNA-II. Patients were prospectively screened for anticipated complications and classified accordingly; complications were centrally reviewed by a complication review board to avoid bias by the treating surgeon, and categorized using a standardized reporting system. Outcome measurements included the occurrence and evaluation of FFCs, the radiological assessment of mismatch and quality of life measured with the EQ-5D score.

RESULTS: 3 Intraoperative and 15 postoperative complications were found in 16/176 patients.

The risk of sustaining any intraoperative or postoperative FFC was 1.7% (3/176; 95% CI: 0.35-4.9) and 8% (14/176; 95% CI: 4.4-13), respectively. The most likely cause for FFCs was the "bone/fracture" factor (9/14 patients). Radiologically detectable contact of the implant with the inner cortex ("mismatch") was reported for 17/173 patients (10%).

CONCLUSIONS: The reported complication risks and mismatches are reasonable for this patient cohort. The geometry- and size-adapted PFNA-II is relatively safe but requires standardized assessment in a larger target cohort.

Copyright Š 2014 Elsevier Ltd. All rights reserved.

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KEYWORDS: Complications; Hip fracture; Intramedullary nail; Mismatch; PFNA; Quality of life; Trochanteric fracture PMID: 24985469

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J Neurooncol. 2014 Oct;120(1):171-8. doi: 10.1007/s11060-014-1540-0. Epub 2014 Jul 25.

Aneurysmal bone cysts of the spine: treatment options and considerations.

Boriani S1, Lo SF, Puvanesarajah V, Fisher CG, Varga PP, Rhines LD, Germscheid NM, Luzzati A, Chou D, Reynolds JJ, Williams RP, Zadnik P, Groves M, Sciubba DM, Bettegowda C, Gokaslan ZL; AOSpine Knowledge Forum Tumor.

Aneurysmal bone cysts (ABCs) are benign bone lesions with annual incidences ranging from 1.4 to 3.2 cases per million people. Approximately, 10-30% of ABCs are found in the spine. Such lesions are traditionally treated with curettage or other intralesional techniques. Because ABCs can be locally aggressive, intralesional resection can be incomplete and result in recurrence. This has led to increased use of novel techniques, including selective arterial embolization (SAE). This study aims to: (1) compare outcomes based on extent of surgical resection, and (2) compare the efficacy of SAE versus surgical resection. Clinical data pertaining to 71 cases of spinal ABCs were ambispectively collected from nine institutions in Europe, North America, and Australia. Twenty-two spinal ABCs were treated with surgery, 32 received preoperative embolization and surgery, and 17 were treated with SAE. Most tumors were classified as Enneking stage 2 (n = 29, 41%) and stage 3 (n = 29, 41%).

Local recurrence and survival were investigated and a significant difference was not observed between treatment groups. However, all three local recurrences occurred following surgical resection. Surgical resection was further categorized based on Enneking appropriateness. Recurrences only occurred following intralesional Enneking inappropriate (EI) resections (P = 0.10), a classification that characterized 47% of all surgical resections. Furthermore, 56% of intralesional resections were EI, compared to only 10% of en bloc resections (P = 0.01). Although SAE treatment did not result in any local recurrences, 35% involved more than five embolization procedures. Spinal ABCs can be effectively treated with intralesional resection, en bloc resection, or SAE. Preoperative embolization should be considered before intralesional resection to limit intraoperative bleeding. Treatment plans must be guided by lesion characteristics and clinical presentation.

PMID: 25059450

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J Bone Joint Surg Am. 2014 Jun 18;96(12):1026-1032. [Epub ahead of print] The Influence of Local Bone Density on the Outcome of One Hundred and Fifty Proximal Humeral Fractures Treated with a Locking Plate.

Kralinger F1, Blauth M1, Goldhahn J2, Käch K3, Voigt C4, Platz A5, Hanson B6.

BACKGROUND: There is biomechanical evidence that bone density predicts the mechanical failure of implants. The aim of this prospective study was to evaluate the influence of local bone mineral density on the rate of mechanical failure after locking plate fixation of proximal humeral fractures.

METHODS: We enrolled 150 patients who were from fifty to ninety years old with a closed, displaced proximal humeral fracture fixed with use of a locking plate from July 2007 to April 2010. There were 118 women and thirty-two men who had a mean age of sixty-nine years. Preoperative computed tomography (CT) scans were done to assess bone mineral density of the contralateral humerus, and dual x-ray absorptiometry of the distal end of the radius of the unaffected arm was conducted within the first six weeks postoperatively. At follow-up evaluations at six weeks, three months, and one year postoperatively, pain, shoulder mobility, strength, and multiple functional and quality-of-life outcome measures (Disabilities of the Arm, Shoulder and Hand [DASH] questionnaire; Shoulder Pain and Disability Index [SPADI]; Constant score; and EuroQuol-5D [EQ-5D]) were done and standard radiographs were made.

We defined mechanical failure as all complications related to bone quality experienced within one year.

RESULTS: After locking plate fixation, fifty-three (35%) of 150 patients had mechanical failure; loss of reduction and secondary screw loosening with perforation were common. CT assessments of local bone mineral density showed no difference between patients with and without mechanical failure (89.82 versus 91.51 mg/cm3, respectively; p = 0.670). One-year DASH, SPADI, and Constant scores were significantly better for patients without mechanical failure (p â&#x2030;¤ 0.05).

CONCLUSIONS: We did not find evidence of an association between bone mineral density and the rate of mechanical failures, which may suggest that patients with normal bone mineral density are less prone to sustain a proximal humeral fracture.

Future studies should target other discriminating factors between patients with and without mechanical failure.

LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

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Copyright Š 2014 by The Journal of Bone and Joint Surgery, Incorporated.

PMID: 24951739

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J Orthop Trauma. 2014 Dec;28(12):707-10. doi: 10.1097/BOT.0000000000000092.

Three-dimensional navigation is more accurate than two-dimensional navigation or conventional fluoroscopy for percutaneous sacroiliac screw fixation in the dysmorphic sacrum: a randomized multicenter study.

Matityahu A1, Kahler D, Krettek C, Stรถckle U, Grutzner PA, Messmer P, Ljungqvist J, Gebhard F.

OBJECTIVES: To evaluate the accuracy of computer-assisted sacral screw fixation compared with conventional techniques in the dysmorphic versus normal sacrum.

DESIGN: Review of a previous study database.

SETTING: Database of a multinational study with 9 participating trauma centers.

PATIENTS: The reviewed group included 130 patients, 72 from the navigated group and 58 from the conventional group. Of these, 109 were in the nondysmorphic group and 21 in the dysmorphic group.

INTERVENTION: Placement of sacroiliac (SI) screws was performed using standard fluoroscopy for the conventional group and BrainLAB navigation software with either 2-dimensional or 3dimensional (3D) navigation for the navigated group.

MAIN OUTCOME MEASUREMENTS: Accuracy of SI screw placement by 2-dimensional and 3D navigation versus conventional fluoroscopy in dysmorphic and nondysmorphic patients, as evaluated by 6 observers using postoperative computerized tomography imaging at least 1 year after initial surgery. Intraobserver agreement was also evaluated.

RESULTS: There were 11.9% (13/109) of patients with misplaced screws in the nondysmorphic group and 28.6% (6/21) of patients with misplaced screws in the dysmorphic group, none of which were in the 3D navigation group. Raw agreement between the 6 observers regarding misplaced screws was 32%. However, the percent overall agreement was 69.0% (kappa = 0.38, P < 0.05). www.aocid.org

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CONCLUSIONS: The use of 3D navigation to improve intraoperative imaging for accurate insertion of SI screws is magnified in the dysmorphic proximal sacral segment. We recommend the use of 3D navigation, where available, for insertion of SI screws in patients with normal and dysmorphic proximal sacral segments.

LEVEL OF EVIDENCE: Therapeutic level I.

PMID: 24694553

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Clinical Research Education by AOCID in 2014

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AO Clinical Investigation and Documentation has been at the forefront of education in clinical research for over a decade.

Beginning with the pioneering "Roadmap to Research" course which has now been taken by thousands of surgeons on four different continents, AOCID has expanded its educational offerings to meet the needs of healthcare professionals around the world at various stages of their careers.

Practical and result-orientated education is offered in a variety of methods with a clear focus on the theory, tools and techniques of clinical research to improve daily patient care.

We offer courses all over the world on an ad hoc basis. All of our training programs are also available in German, and we are able to offer selected courses in other languages.

On the next page you can see an overview of the educational courses / events that AOCID gave in 2014. There were 14 events in total.

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Overview of AOCID educational events in 2014 Date from JANUARY 24.01.2014

Date to

City

Country

Event Name

25.01.2014

Prague

Czech Rep.

AOTrauma Grant Writing Course

MAY 14.05.2014

14.05.2014

Xi'an

China

How to successfully set-up your own clinical study in spine research

15.05.2014

15.05.2014

Seoul

South Korea

Roadmap to Research

31.05.2014

31.05.2014

Queensland

Australia

Roadmap to Research lecture

01.06.2014

01.06.2014

Brisbane

Australia

Outcome research lecture incl.

AOPOC

03.06.2014

03.06.2014

Brisbane

Australia

Roadmap to Research

SEPT. 21.09.2014

21.09.2014

Prague

Czech Rep.

Good Clinical Practice Course

26.09.2014

27.09.2014

D端bendorf

Switzerland

AOSpine Mentees - Med Writing and Statistics

OCTOBER 02.10.2014

04.10.2014

Hong Kong

China

AOCID Study Coordinator Course

NOVEMBER 08.11.2014

09.11.2014

Taipei

Taiwan

AO Medical Writing Course

24.11.2014

24.11.2014

Bangalore

India

Study Set-Up course

DECEMBER 02.12.2014

2-Dec-14

Zurich

Switzerland

RedCap Training

12.12.2014

13.12.2014

Davos

Switzerland

Good Clinical Practice course

13.12.2014

14-Dec-14

Davos

Switzerland

Combined Clinical Research course

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AOCID clinical research fellows in 2014

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Luciano Andres Rossi, Argentina, AOTrauma Clinical Research Fellow January to March 2014

Luciano Rossi (blue shirt) surrounded by AOCID employees.

After finishing my medical studies in the University of Buenos Aires in Argentina, I started my residency in orthopedics at the Italian Hospital of Buenos Aires in 2009. In 2010 I attended the AOTrauma Principles Course and in 2012 the AOTrauma Advances Course. Jorge Barla, a member of the trauma team of my hospital and an AO faculty member, made me aware of the fellowship.

There were two main reasons for me to do the fellowship. The first one was to be able to understand and identify the best available evidence for rational decision making in our daily practice. The second one was to gain training and experience in all phases of clinical research to improve the quality of my studies in the future. I focused on the following project while at AOCID, Adhesive Capsulitis of the shoulder.

Intra-articular injections without image control accelerate pain and functional recovery.

I had a great and very useful experience in Switzerland. I gained training and experience in all phases of clinical research. It was very interesting to see how work is conducted in a multicenter study, the problems that arise and how they are resolved. All the members of the AOCID team treated me very well, showed great dedication and commitment and I am very grateful for that.

The most important thing is that I gained an insight into all parts of a clinical trial, which will really help me to do clinical research in my home hospital. When I return to Argentina, I believe that my experience studying here will open new doors, opportunities and perspectives for me to do clinical research in the future. I enjoyed the great time working as an AOCID fellow. I will recommend this fellowship to my partners because I think it is a very valuable experience.

Luciano Andres Rossi, Argentina. www.aocid.org

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Aijaz Naik, India, AOCMF Clinical Research Fellow April to May 2014

Aijaz Naik (center) pictured with AOCID colleagues upon finishing his fellowship.

I have been an AO fan for a long time. After finishing my masters in oral and maxillofacial surgery in 2009 at King Georgeâ&#x20AC;&#x2122;s Medical University in Lucknow India, I became a Registrar in 2009 and joined the Department of Oral and Maxillofacial Surgery GDC Srinagar in 2010, in my homeland.

During the same year I attended the AOCMF Principles Course in Lucknow and I found it very much worthwhile. I attended one more AOCMF Advances Course in 2011 in Bangalore which was very interesting. During these events I realized that the AO Foundation is an effective tool for imparting education all over the world to interested candidates. I therefore began to think of doing a fellowship and getting involved with the AO Foundation. Fortunately, I was selected for an AOCMF fellowship in 2012 and my fellowship center was Lomas Verdes hospital in Mexico under the guidance of Prof Cienfuegos Ricardo. This is a very busy trauma hospital and I gained a lot of experience in dealing with all sort of facial trauma reconstruction which was very helpful for me.

However, during all of these events, I was looking for a fellowship which would teach me about clinical research and documentation. Fortunately I came to know about the AOCID fellowship via the AO Foundation website. I studied the program besides going through the comments of past fellows and began to realize that, â&#x20AC;&#x153;Yes! This is the fellowship I'm looking for." Within days I had submitted my application form.

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thought it would be.

While going through the fellowship period, I begin to realize how important it is to learn about conducting clinical research documentation in a scientific way. I hope I can be very helpful to my students in teaching Good Clinical Practice and scientific methods of documentation. My project of study during the fellowship period was titled 1.5 mm miniplate vs. 2.0mm miniplate in the management of simple unilateral mandible angle fracture management: a randomized clinical trial.

The fellowship was very helpful for me to learn about all the phases of clinical research, including: •

the idea phase

•

documentation

•

statistics

•

systematic literature surfing

•

critical appraisal of literature

In addition, I was given a license to use and learn Stata statistical software for one year which shall be very helpful for me to learn more about it. I additionally passed an online Good Clinical Practice exam. This course gives a full insight into the most important aspects of clinical research and documentation. The AOCID office also managed to organize a short period of work in Basel University Hospital at the end of my fellowship. I found it interesting for two reasons. Firstly, because this hospital has remained the working place for two giant academicians and clinical researchers, namely Prof Spiessl and Prof Prein, who have contributed so much to the management of craniomaxillofacial trauma. Secondly, this hospital has continued to collaborate with the AO Foundation and has developed into a world famous research institute which uses the latest sophisticated gadgets for clinical research. I was fortunate enough to personally meet Prof Prein who is retired from the service but is still continuing with his clinical research.

Apart from the AOCID fellowship itself, it was a wonderful experience to get to know about Swiss culture and explore the beautiful places in Switzerland. To my surprise, I found every inch of Switzerland to be more beautiful than I had imagined. Workers from other countries are present in Switzerland, working in many different sectors.

They have integrated into this rich culture which clearly shows the foresightedness and forbearance of Swiss people which is amazing.

I express my sincere gratitude to my fellowship mentor, Dr Alexander Joeris, whose encouragement, guidance and support, from the initial to the final level enabled me to develop an understanding of the subject. Also my first debt of gratitude must go to AOCID Director, Dr Beate Hanson, who patiently provided the vision, encouragement and advice necessary for me to proceed through the fellowship. Members of the

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AOCID team in Duebendorf and Davos also deserve my sincerest thanks, their friendly assistance has meant more to me than I could ever express.

Dr Aijaz Ahmad Naik, MDS maxillofacial surgery, Kashmir, India.

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Alessandro Aprato, Italy, AOTrauma Clinical Research Fellow September to December 2014

Alessandro Aprato (center with computer) in the regular AOCID Monday morning meeting

I work in the Hip and Pelvis Unit of the University of Turin in Turin, Italy.

After being involved in several low quality clinical studies, I was looking to improve my ability to design, perform, analyze and finalize clinical studies.

AOCID (AO Clinical Investigation and Documentation) is famous in running international multicenter clinical trials from the planning phase through to publication and offered me a good chance to become well-trained in this discipline. I had great time working as an AOCID fellow, and I will take this experience forever with me.

The study I worked on with AOCID is on the socioeconomic burden of acetabular and pelvic fractures.

During the fellowship, several ideas for clinical studies came into my mind and I canâ&#x20AC;&#x2122;t wait to start designing these new studies. I do believe that this experience will increase the quality of my future studies and I also hope this will help my academic career.

Alessandro Aprato, Turin, Italy.

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Matheus Azi, Brazil, AOTrauma Clinical Research Fellow September to December 2014

Matheus Azi (second from left) pictured with AOCID colleagues

I work as an orthopedic trauma surgeon in Salvador, Brazil. I attended the Roadmap to Clinical Research course and other AOCID activities which were promoted by AOTrauma in Latin America. In those meetings I had the opportunity to learn about the work conducted by AOCID and how the fellowship could be an opportunity to improve my skills as a researcher.

I was particularly taken by this quote by Maurice E. Muller: â&#x20AC;&#x153;Our effort to document our patient case studies was the start for evidence based medicineâ&#x20AC;?.

My project during my fellowship was titled, "Treatment of Post-traumatic Bone Defects of the Lower Limb Using the Biomembrane Technique Followed by Autologous Bone Graft".

During my fellowship I had opportunity to discuss my projects with the AOCID team of experts in clinical research. I also could sample life in the AO offices where there are employees from many different parts of the world.

While on my fellowship I could also begin to understand the complexity of conducting research on an international basis, and the issues that arise when dealing with different countries, languages and regulations.

I hope in the future to develop new projects together with AOCID and AOTrauma, projects which can benefit the clinical research conducted in my region.

Matheus Azi, Salvador, Brazil.

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Major AOCID-related stories on AO websites in 2014

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AOCID, the first 15 years 3 February 2014 A look back at the history of clinical investigation in the AO. 15 x 15 commemorative badges to be won!

"The First 15 Years" badge.

The history of AO Documentation AO Documentation began operations in 1959 and around 1,000 cases were recorded during the first year of operation alone. It was this documentation of fracture cases that created the necessary scientific evidence to prove the value of internal fracture fixation to an initially skeptical public. AO Documentation's unique repository of collected cases provided the basis in the 1980s for the AO/OTA Fracture and Dislocation Classification â&#x20AC;&#x201C; Long Bones, a system known and used as standard by surgeons around the world.

However, by the 1990s it was realized that the concept of documentation no longer met contemporary standards and that a reorganization of AO clinical study activities was necessary to include prospective trials in order to proactively answer clinical questions.

Win an AOCID "The First 15 Years" badge We have 15 x 15 commemorative badges to give awayâ&#x20AC;&#x201D;a total of 225! Simply send us an e-mail with your name and full address. The badges will be sent on a "firstcome, first-served" basis so send your e-mail now for the chance to win a small part of AO history. www.aocid.org

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The beginnings of clinical investigation in the AO AO Clinical Investigation and Documentation (AOCID) was officially founded in 1998 to conduct clinical studies. Ruedi Moser was the first director and so began the move from documentation center to clinical investigation center. Beate Hanson accepted an offer in 2002 from the then AOCID Chairman David Helfet and became AOCID director, a position she still holds today.

The AOCID mission is to provide evidence-based knowledge through independently conducted clinical studies, education and methodological services. In its first 15 years, AOCID has grown beyond all expectations in terms of both size and capabilities. From just a handful of clinical trials in the early years, AOCID is currently involved in approximately 50 multicenter international studies of every type of study design. In addition to this, around 20 Focused Registry projects are either running or in development. The internationalization of AOCID is also evident. Over 330 different clinics scattered around the globe have participated in clinical investigations. Over the past 15 years, well over 9,000 patients have been recruited to an AOCID study.

Careful planning and processes are key to success in clinical trials. AOCID is ISO 9001 certified and an increasing amount of outside vendors have audited and appointed AOCID a "Preferred 3rd Party Provider" in recognition of the expertize housed within.

AOCID is more than just clinical investigation While AOCID carries out the functions of a typical Contract Research Organization, one element which sets AOCID apart from industry is the focus on spreading knowledge about evidence-based medicine (EBM). For example, Beate Hanson's Roadmap to Research course (an introduction to EBM) has been given on 4 different continents and in 2013 celebrated a decade as a permanent fixture at the AO Davos Courses. Around 20 young surgeons have availed of the unique clinical research fellowship to spend three months at a time in the AOCID offices to learn about the planning and conduct of studies. More courses are in the pipeline to suit the growing needs of healthcare professionals.

As a result of AOCID's experience, the AO Clinical Study Center (AOCSC) global qualification program was developed. Among the advantages to becoming an AOCSC clinic are increased efficiency in clinical studies and ensured ethical and regulatory compliance (ICH-GCP / ISO 14155). Over 30 centers from Aarau to Woolloongabba are part of the AOCSC program. The dedicated website: www.aocsc.org has all the information.

The first 15 years at AOCID were exciting ones as capabilities and networks were built up. As a result of all the hard work since 1998, the promise of the next 15 years and beyond for AOCID seems great. www.aocid.org

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Our thanks to the surgeons, study coordinators, patients, AOCID advisors and employees who have all played their part in our success in the 15 years of AOCID.

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AO Patient Outcomes Center 27. March 2014 AOPOC: revolutionizing the collection of patient outcome measures! First patients recruited in Boston for this AOCID initiative.

Dr Mark Vrahas, Principal Investigator for the AO Patient Outcomes Center pilot study.

At the beginning of March 2014, the AO Patient Outcomes Center (AOPOC) pilot study recruited its first patients in Boston, USA. We caught up with Dr Mark Vrahas, Principal Investigator for this study, to find out more about this new departure in the collection of patient outcome measures.

Dr Vrahas, what is the AOPOC project all about?

The AO Patient Outcomes Center is a scientific tool to simplify collection of patient outcome measures for surgeons and patients. The tool uses Computer Adaptive Testing technology to tailor the most appropriate series of questions for each patient based on their individual responses. Compared to the traditional paper collection of patient reported outcome data, this tool reduces the burden on patients because they have to answer much fewer questions. This allows patient-reported outcome assessments to be performed quickly and efficiently in a busy routine clinical setting.

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How will the AOPOC tool work?

Patients typically answer the questions on an iPad in the waiting room and then review and discuss the results with their clinician during the consultation. The results are displayed in both tabular and graphical form and allow a patient's progression over time to be quickly viewed and assessed. This leads to better communication between patients and their physicians, and ultimately to improved patient care.

Can it be used by any doctor?

Right now we are testing the system at four hospital systems: Mass General Hospital, Brigham and Womenâ&#x20AC;&#x2122;s Hospital, Maine Medical Center, and Northwestern University.

After these alpha tests we will open the tool to 20 more sites for beta testing. Once all the testing is complete, the plan is to have the tool available for general release by early 2015.

Can it be used in any population?

The AOPOC tool is optimized for orthopedic patients, but there is no reason that it cannot be used for all medical conditions. It uses outcome measures created by the NIH to assess all domains of health. The default measures are for physical function and pain which obviously very important in orthopedics, but with the simple click of a tab, measures addressing all areas of health can be added.

Who else was behind the development of the AOPOC? As you can imagine for such a complex project, a large team was involved. We are particularly indebted to Drs Mike Stover, Mike Weaver, Ray White, Bruce Sangorgian, and Bob O'Toole who volunteered a great deal of time and early morning conference calls to develop this tool. We had wonderful collaborators from Northwestern University led by Nan Rothrock; Nancy Holmes, the director of AO North America (AONA); and Beate Hanson, the director of AO Clinical Investigation and Documentation (AOCID) who have worked tirelessly to keep this project on track.

Finally, we are indebted to AONA and AOTrauma International for their support, encouragement and funding for this project.

Thank you very much Dr Vrahas for this interview and best of luck to you and the rest of the AOPOC team as you continue to develop and hone this exciting tool.

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Images

Completing forms the old fashioned way.

Paper based outcome measurements.

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AO External Fixator survey is now open 17. June 2014 We would like YOUR opinions on this topic.

The AO External Fixator Working Group (EFWG) would like to have the AO Community's feedback on their opinions and use of External Fixators in the clinic.

Your answers will be a great help to the EFWG group in setting future directions.

We have set up a user-friendly one page online questionnaire for this purpose. It only takes a couple of minutes to complete.

To access the survey simply click on the link below, or cut and paste the entire URL into your browser:

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https://www.surveymonkey.com/s/Ex_Fix_Survey If you experience any technical difficulties accessing or submitting the survey please contact aocid@aofoundation.org.

Your answers will be invaluable in helping us to learn more about trends in the use of external fixators. Please be assured that all your answers are anonymous.

Thank you in advance for your participation.

In the name of the EFWG (External Fixator Working Group) Theddy Slongo, Chairman

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AO Study Coordinator Course 13. November 2014 A record number of participants took this unique course in Hong Kong.

A scene from the tour through the AOCSC qualified clinic.

First AO Study Coordinator Course in Asia At the start of October 2014, some 22 participants from China, Hong Kong, India, Thailand, Australia, and Singapore met at the Queen Mary Hospital in Hong Kong to take part in the third AO Study Coordinator Course. Despite the course title, the participants were not just study coordinators, there were doctors active in trauma, orthopedics and dental science, an epidemiologist, as well as clinical trial center collaborators among the attendees.

The course, developed by AO Clinical Investigation and Documentation (AOCID), was held at Queen Mary Hospital under the patronage of Dr Frankie Leung. Dr Leung, a longstanding AO member and AO Trustee, is employed by Queen Mary Hospital, a clinic which has been an AO Clinical Study Center (AOCSC) since 2011.

Among the very relevant topics covered were Good Clinical Practice (GCP), documentation, monitoring, study termination, overcoming challenges in the conduct of clinical research. A general program for this course is available for download.

In addition to the tuition and workshops, the course participants enjoyed a tour through the wards and clinical research facilities of Queen Mary Hospital. www.aocid.org

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Presentations were given by Kathine Ching and Grace Yuen about their roles in the clinical research team at the clinic and their experiences as study coordinators on trials.

Enhanced course content AOCID has worked with AO Education on honing the course content over the past year. Eight distinct competencies that participants learn on this educational event have been developed and are listed below: 1. Manage own role and define position within the study/clinical setting 2. Read, extract, condense protocols and clarify criteria incl. understanding of clinical research concepts 3. Perform the study coordinator tasks 4. Train the study team and spread knowledge and awareness 5. Communicate with team, patients, external bodies and other departments 6. Manage regulatory issues 7. Manage sponsors 8. Build an appropriate infrastructure The participants were made aware of these competencies at the beginning and during the course. Reflection sheets were integrated into the course program to allow the participants to document what they had learned and to define specific action points for their daily work as a study coordinator.

The participants speak It's a great course and it will lead me to go into clinical research.

Attending Physician Workshops are good as it gives participants from different countries the chance to discuss and exchange ideas.

Senior Research Coordinator The course contains many cases which we might meet in our daily work.

Study Coordinator Our thanks go to the participants in Hong Kong and our hosts at the Queen Mary Hospital for all of their contributions to a very successful course.

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Details of future courses will be advertised on the AO Foundation's website and posted on our dedicated website: www.aocid.org/studycoordinator. To make sure you are among the first to know, you can join our Study Coordinator mailing list by sending an e-mail to Marina K端ng.

Images

Participants listening to a lecture.

Denise Hess explaining an exercise to a group in the Queen Mary Hospital.

Role-play workshop at the Study Coordinator Course 2014.

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Call for AO Clinical Study Center (AOCSC) Qualifications funded by AOTrauma 23. October 2014 AOTrauma offers two selected clinics an exclusive opportunity to qualify for clinical research.

The AO Foundation maintains a system to standardize and harmonize processes in the conduct of clinical studies at collaborating investigational clinics. Study centers involved in this program are qualified as 'AO Clinical Study Centers' (AOCSC) network partners by the AO Foundation. AO Clinical Investigation and Documentation (AOCID) conducts and manages the AOCSC qualification program.

The AO Clinical Study Center (AOCSC) program spans the world. AOTrauma is proud to offer two clinics an exclusive opportunity to be qualified for clinical research.

Click here to apply.

Read the detailed information about this qualification program in this Error!

Hyperlink reference not valid.; or visit the website at www.aocsc.org.

In order to promote the conduct of clinical research among the AO network, the AOTrauma Research Commission has decided to cover the qualification fee of CHF 6,000 (plus expenses) for two selected clinics.

The selection process will be based on the online application form (see link below).

Interested centers need to submit a letter of motivation, which will be considered in the clinic selection process (refer to the last section of the online survey).

The questionnaire will be open until Thursday 13th of November, 2014. www.aocid.org

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Click here to access the online AOCSC questionnaire If you have any questions about this process, please send an email to: research@aotrauma.org.

The AOTrauma Research Commission looks forward to receiving your application.

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AOTrauma Course—Grant Writing 13. April 2014 This new course premiered in Prague, Czech Republic, in January 2014.

Group picture with the participants of the AOTrauma Grant Writing course with the course Chair Michael Blauth and the faculty Beate Hanson, Werner Schmölz, and Alexander Joeris, Prague, Czech Republic, 2014

More than 20 participants from eleven different countries gathered in Prague for two days at the end of January 2014 for the inaugural AOTrauma Course—Grant Writing.

This course required much commitment from the participants as they were required to submit a draft study proposal prior to attending the course that lasted for over two days. In preparation, the participants were directed to the online AOTrauma Webinar—How to write a good clinical study grant application.

The course program Guided by expert faculty including Michael Blauth, Beate Hanson, Werner Schmölz, and Alexander Joeris, the participants learnt the theories underpinning clinical research. They also had the opportunity to discuss their own projects in depth with the onsite expert faculty.

The topics covered included: •

The meaning of different kinds of evidence, causality, and confounding

•

How to formulate a focused clinical question

•

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•

How to critically appraise the literature

•

How to summarize the relevant literature

•

Study designs (sampling, power analysis, and data recording)

•

Study financing

A course with a difference What sets this course apart from other available grant writing courses is the individualized attention to study proposals, the expert input from the faculty with a background in medicine and clinical research; and the successful application for grants. A very concrete benefit is that the participants can polish their study proposals in a very short amount of time.

Suitably armed with the knowledge on how to write a robust grant application, it is expected that all 23 participants will go on to submit their proposals to AOTrauma.

Rationale for the course Surgeons receive their medical education at university and continually add to their knowledge by attending further AO courses and congresses; and by keeping up to date with the scientific literature. However, there is also a pressing need for surgeons to learn about different but related topics. Since the body of scientific evidence is continually added to and refined through the publication of new studies, surgeons need to conduct clinical research. Such studies require financing. This implies that the knowledge on how to write a grant application is invaluable to a surgeon with an idea for a clinical study in order to see it through.

Feedback from the course participants As part of the feedback form especially developed for this course, participants were also requested to submit quotes to be used anonymously. Among the comments received were: "Excellent way to learn how to apply for a grant."

"Well-structured course, friendly environment, and experienced speakers."

"Nicely outlined roadmap for structured grant writing. I highly recommend it."

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Images

Participants interacting during a practical exercise under the supervision of the course Chair Michael Blauth, AOTrauma Grant Writing Course, Prague, Czech Republic, 2014

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AOSpine Europe's clinical study moves ahead thanks to teamwork.

Successful SCI-POEM investigator meeting in Switzerland.

19. May 2014

Every clinical study is faced with challenges and it is how the researchers deal with these difficulties than can ultimately decide the success or otherwise of a clinical trial.

AOSpine Europe's SCI-POEM study began with the development of a clinical investigation plan in January 2012. The study now boasts 17 recruiting clinics in 12 countries, supported by two rehab centers in the United Kingdom which concern themselves with the important follow-up part of the study.

Representatives from 18 of the trial centers met on 6 May 2014 in Zurich, Switzerland, to highlight study-related issues and to work together with their colleagues to find pragmatic solutions. The attendees were drawn from different areas of specialization and everyone could draw on the breadth of experience in the room. There were spine surgeons, rehabilitation physicians and study coordinators, as well as AOSpine and AO Clinical Investigation and Documentation (AOCID) employees.

Also present at the meeting was the new AOSpine Europe Research Officer, Lorin Benneker, who was there to oversee the project's progress. He has replaced SCIPOEM's Co-Principal Clinical Investigator, Giuseppe Barbagallo, in this important role.

Many of the representatives also took the opportunity to hold side meetings on either day of the main event. Some researchers availed of the chance to hold an individual consultation with AOCID regarding their particular study issues. This arrangement proved to be very useful for everyone involved.

One of the issues which were discussed, one which is typical at investigator meetings, was the challenge of meeting the recruitment target of 300 patients. Currently 61 patients have been enrolled and most clinics have already gathered their first experience in recruitment on this study. Recruitment for the SCI-POEM study is particularly challenging due to the acute and complex nature of the injury and the emergency situation in which study-suitable patients present for treatment.

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multiple neurological examinations being performed in patients enrolled in the study.

A research team which works together well is a prerequisite for success on a clinical study like this and teamwork and coordination was the focus of a workshop held during the meeting. The attendees were also schooled in study-specific adverse event documentation and reporting.

The SCI-POEM clinical study at a glance Although injuries to the spinal column represent a relatively small proportion of all traumatic injuries, spinal injuries have one of the highest impacts on functional outcomes and employment status. More than just an injury to the spinal column, traumatic spinal cord injury (tSCI) is a devastating disorder which severely affects patients' physical and psychosocial well-being. The incidence of tSCI is estimated to be somewhere between 11 to 53 new cases per million of the population annually.

This multicenter, prospective, observational cohort study is designed to evaluate if early decompressive spinal surgery occurring within 12 hours post-injury is superior in improving neurological motor outcomes, compared to late decompressive occurring more than 12 hours and within 14 days after the traumatic spinal cord injury.

As already stated, target recruitment for this study is 300 patients, all of who will be followed-up for 12 months. The sites are all located in Europe where patients are generally transported more swiftly to a treatment clinic compared to other geographic regions of the world. Recruitment began in 2013, and the final report is expected in 2017.

Next steps / outlook Post-meeting, a close eye will be kept on the study's recruitment figures. It is expected that the patient numbers will increase once all recruiting sites come on stream.

However, the option of including an additional clinic in the study is being kept in reserve should it be needed.

Voices from the meeting "I was extremely impressed with the level of organization, commitment and enthusiasmâ&#x20AC;Śit was not only informative but also enjoyable." www.aocid.org

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â&#x20AC;&#x201C; An investigator, Ireland.

"It was a very interesting and as far as I am concerned, very instructive and efficient meeting!" â&#x20AC;&#x201C; An investigator, Germany.

"It was a very positive experience. I have attended several events like this but this was the first time I noted that all team members were dedicated, enthusiastic and without any hesitation in sharing opinions and experiences. Conditions like this create a good basis and will lead to a lasting team-building process and excellent study results."

- A senior investigator.

Congratulations to everyone who attended the meeting, Principal Clinical Investigator Allard JF Hosman, the Co-Principal Clinical Investigators Drs Barbagallo and van Middendorp, AOSpine Europe and AOCID for preparing the meeting, and last but not least, a big thank you to all of the members of the SCI-POEM research teams at the 19 different centers across Europe.

Further information If you would like to know more about the SCI-POEM project, please click here for the dedicated study webpage on the AOSpine website.

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AO Strategy Fund update 16. April 2014 Eleven projects have been shortlisted for the next phase of the Strategy Fund.

The AO Strategy Fund, with an annual budget of CHF 5 million for important new strategic initiatives, received 107 pre-proposals in January 2014, requesting annual funding of more than CHF 10 million.

The response to this first call for applications, in terms of both quality and quantity, was overwhelmingly positive. Approximately two-thirds were submitted by AO members and one-third by employees. Pre-proposals came from 24 countries, with the highest number coming from Switzerland (30), the US (14), Iran (10), Germany (9) and China (6).

These pre-proposals were assessed by the AO Foundation Board (AOFB) at its meeting in March 2014, as the first step in a rigorous peer review process. They were evaluated for their degree of innovation, their impact on the mission of the AO, their feasibility, their impact on operations, and their ability to foster cooperation across the Clinical Divisions.

With such a high number of applications received, difficult choices had to be made.

Priority went to projects not seeking investment in clinical or basic research, infrastructure, hardware, or individual education or fellowship proposals.

Eleven projects have been shortlisted for the next phase, with applicants asked to submit a more detailed proposal for the next AOFB meeting in June 2014. Topics include 3D printing, surgery simulation, pre-clinical facilities, an interactive video portal, a research animal models database, trauma prevention, faculty education, pediatric surgery reference, and a clinical trials and regulatory congress. www.aocid.org

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Nine other pre-proposals were considered more appropriate to be evaluated, and possibly financed, by other funding sources within the AO. Some rejected pre-proposals may be relevant to other potential funding bodies within the AO, e.g. research grants or via the Clinical Divisions.

If your application was rejected, we encourage you to explore these alternatives to understand if your idea could be pursued through these channels.

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AO Clinical Investigation and Documentation Clavadelerstrasse 8 7270 Davos Switzerland Phone +41 44 200 24 85 Fax +41 44 200 24 60 aocid@aofoundation.org www.aocid.org

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