Page 1

LIGAMENT TOOLKIT


Ligament Tool Kit Table of Contents 1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared with Allograft, Carey et al. A. BTB i. BTB Overview B. BTB Select ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide C. Achilles v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato D. Non-Bone Tendons vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones, et al.


g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus NonIrradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al. A. BioCleanse® i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process, Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration, Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al. 3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized Through the BioCleanse Process, Pedroso & Myrick 4. Specifications a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring Autograft Combined With Tibialis Anterior Allograft, Tejwani 5. Fees a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees


products


ACHILLES

PRODUCTS


Achilles Tendons

PROVEN Sterilization without Irradiation

Achilles tendons allow for multiple techniques and fixation options in ligament reconstruction procedures. Achilles tendons distributed by RTI Biologics are sterilized without the use of irradiation through the patented BioCleanse® Tissue Sterilization Process, which inactivates or removes potential pathogens while maintaining the tissue’s biomechanical properties.

Achilles Tendon Options:

Pre-Shaped

Pre-Trimmed

Conventional

Achilles Tendon Benefits • Allows for multiple fixation techniques • Minimizes operating time and simplifies surgical technique as compared to autograft • Eliminates donor site morbidity • Multiple bone block options allow the surgeon to shape the graft into desired form and size at time of surgery


Pre-Shaped Benefits • Natural calcaneus bone block allows for multiple fixation types • Pre-shaping of the bone block decreases OR time

Pre-Trimmed Benefits • Natural calcaneus bone block allows for multiple fixation types • Larger pre-trimmed bone block provides flexibility for the surgeon to shape the bone to best fit the patient • Excellent option for both primary and revision applications

Conventional Benefits • Natural calcaneus bone block allows for multiple fixation options • Provides the largest bone block possible for use in various ligament reconstruction procedures (e.g. primary, revision, PCL, etc.)

To order, call RTI directly: 800.624.7238.

11621 Research Circle Alachua, FL 32615 Toll Free: 877.343.6832 Fax: 386.418.0342

www.rtibiologics.com ©2010 RTI Biologics, Inc.

6247 R0 12-15-10


Ligament Tool Kit Table of Contents 1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared with Allograft, Carey et al. A. BTB i. BTB Overview B. BTB Select ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide C. Achilles v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato D. Non-Bone Tendons vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones, et al.


g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus NonIrradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al. A. BioCleanse® i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process, Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration, Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al. 3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized Through the BioCleanse Process, Pedroso & Myrick 4. Specifications a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring Autograft Combined With Tibialis Anterior Allograft, Tejwani 5. Fees a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees


Allograft Processing


American Journal of Sports Medicine http://ajs.sagepub.com

Nonirradiated Versus Irradiated Achilles Allograft: In Vivo Failure Comparison Matthew RappĂŠ, MaryBeth Horodyski, Keith Meister and Peter A. Indelicato Am. J. Sports Med. 2007; 35; 1653 originally published online May 21, 2007; DOI: 10.1177/0363546507302926 The online version of this article can be found at: http://ajs.sagepub.com/cgi/content/abstract/35/10/1653

Published by: http://www.sagepublications.com

On behalf of: American Orthopaedic Society for Sports Medicine

Additional services and information for American Journal of Sports Medicine can be found at: Email Alerts: http://ajs.sagepub.com/cgi/alerts Subscriptions: http://ajs.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav Citations (this article cites 36 articles hosted on the SAGE Journals Online and HighWire Press platforms): http://ajs.sagepub.com/cgi/content/abstract/35/10/1653#BIBL

Downloaded from http://ajs.sagepub.com at UNIV OF FLORIDA Smathers Libraries on September 27, 2007 Š 2007 American Orthopaedic Society for Sports Medicine. All rights reserved. Not for commercial use or unauthorized distribution.


Ligament Tool Kit Table of Contents 1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared with Allograft, Carey et al. A. BTB i. BTB Overview B. BTB Select ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide C. Achilles v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato D. Non-Bone Tendons vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones, et al.


g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus NonIrradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al. A. BioCleanse® i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process, Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration, Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al. 3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized Through the BioCleanse Process, Pedroso & Myrick 4. Specifications a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring Autograft Combined With Tibialis Anterior Allograft, Tejwani 5. Fees a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees


BIOCLEANSE

ALLOGRAFT PROCESSING


Competitor Comparison Placeholder


Competitor Comparison Placeholder


Ligament Tool Kit Table of Contents 1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared with Allograft, Carey et al. A. BTB i. BTB Overview B. BTB Select ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide C. Achilles v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato D. Non-Bone Tendons vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones, et al.


g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus NonIrradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al. A. BioCleanse® i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process, Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration, Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al. 3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized Through the BioCleanse Process, Pedroso & Myrick 4. Specifications a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring Autograft Combined With Tibialis Anterior Allograft, Tejwani 5. Fees a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees


age


The Statistics 2008 United States Death Statistics

2008 United States Donor Estimates

This data was culled from three major sources: 1. U.S. Census Annual Estimates of the Resident Population for the United States, Regions, States, and Puerto Rico: April 1, 2000 to July 1, 2008 2. NATIONAL VITAL STATISTICS REPORTS; U.S. Decennial Life Tables for 1999–2001, United States Life Tables 3. http://www.organtransplants.org/understanding/tissue/ - used for total tissue donors per year statistic


Applying the Statistics to Allograft Tissue bank xyz distributes 400 grafts per month. If you apply the death stat % then you can assume the following: < 40 yr = 64 (16%) 40 – 55 yr = 144 (36%) 55 – 65 yr = 192 (48%) If you assume failures due solely to age and you assume the surgeon perception that grafts over 40 are inferior and will fail, then 85% of any tissue banks’ grafts would fail. THIS IS NOT HAPPENING; THIS IS NOT THE ACCEPTED FAILURE RATE FOR ALLOGRAFT. The commonly accepted failure rate of allograft is 3-5%.


Ligament Tool Kit Table of Contents 1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared with Allograft, Carey et al. A. BTB i. BTB Overview B. BTB Select ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide C. Achilles v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato D. Non-Bone Tendons vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones, et al.


g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus NonIrradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al. A. BioCleanse® i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process, Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration, Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al. 3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized Through the BioCleanse Process, Pedroso & Myrick 4. Specifications a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring Autograft Combined With Tibialis Anterior Allograft, Tejwani 5. Fees a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees


specifications


Ligament Reconstruction: Product Label Measurements G

G

NE BO OCK BL

A

A E

A

C

C

AR

LL

TE PA

D

F B

B I

D

H E

F

BTB Pre-Shaped and Hemi

BTB Select

A. Width of tendon at insertions B. Length of tendon between bone blocks* C. Total length of graft D. Width of tibia bone block at insertion E. Width of patellar bone block at insertion F. Height of tibia bone block including tendon G. Length of tibia bone block H. Height of patellar bone block including tendon I. Length of patellar bone block

A. Width of tendon at insertions B. Length of tendon between bone blocks C. Total graft length not including tail D. Length of calcaneus bone block E. Circumference of assembly F. Length of tail G. Width of calcaneus bone block H. Height of calcaneus bone block

*Shortest measurement (medial or lateral)

C

C

D

D

E

B B

E

A

A

Achilles Pre-Shaped

Achilles Pre-Trimmed/Conventional

A. Total length of graft B. Tendon width C. Calcaneus bone block length D. Calcaneus bone block diameter E. Circumference (pull through) up to flare

A. Total length of graft B. Tendon width C. Calcaneus bone block length D. Calcaneus bone block width E. Calcaneus bone block height

Not for distribution.

H


C B A

The pull-through circumference (folded diameter) is determined by pulling the folded tendon through the appropriate hole in the sizing block.

Tibialis/Peroneus

A. Length B. Width* C. Pull-through Circumference (folded diameter)*

E D C

Semitendinosus

The pull-through circumference (folded diameter) is determined by pulling the folded tendon through the appropriate hole in the sizing block.

C. Length D. Width* E. Pull-through Circumference (folded diameter)*

B A

Gracilis

A. Length B. Width*

*Measured at widest point

To order, call RTI directly: 800.624.7238.

11621 Research Circle Alachua, FL 32615 Toll Free: 877.343.6832 Fax: 386.418.0342

www.rtibiologics.com Not for distribution.

Š2010 RTI Biologics, Inc.

12-08-10


Ligament Tool Kit Table of Contents 1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared with Allograft, Carey et al. A. BTB i. BTB Overview B. BTB Select ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide C. Achilles v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato D. Non-Bone Tendons vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones, et al.


g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus NonIrradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al. A. BioCleanse® i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process, Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration, Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al. 3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized Through the BioCleanse Process, Pedroso & Myrick 4. Specifications a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring Autograft Combined With Tibialis Anterior Allograft, Tejwani 5. Fees a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees


fees


FAQ’s & Handling Objections – Fees

Why is RTI tissue at a premium fee? 1) Sell the science BioCleanse® sterilization process o BioCleanse® is a validated low temperature chemical sterilization process. o It uses a combination of mechanical and chemical processes (oscillating positive and negative pressure in the presence of the chemical agents). o BioCleanse removes blood and lipids, and inactivates or removes potential contaminants, leaving the tissue biocompatible. o Bone grafts are terminally sterilized by a validated method to achieve a Sterility Assurance Level of 10-6. Sports medicine tendons are sterilized without irradiation. Quality Processing Exceptional recovery and processing of grafts providing consistent high quality allografts. RTI Innovations RTI invests money into research to create innovation in the allograft space like BioCleanse®, Tutoplast, Cancelle SP, and assembled technology.

2) Is RTI willing to discount graft fees? Understand the facility’s target. Is it price? Is it volume? Is it graft type? Find out the facility usage data before committing to a discount. RTI is willing to discount graft fees through the Flex Fee Program. Please work with your RSM on this. Bundle tissue so that you are maximizing the facilities potential to order multiple graft types at a lower average fee.

3) I am satisfied with my current supplier; why should I change to RTI Biologics? Ask probing questions, such as: “If you could change one thing about your current supplier what would it be?” (Here you are trying to find a value point for that facility)


“What target overall biologics spend goals are you looking to achieve this year?” (Here you are trying to start the bundling conversation.) “Considering the variability of human tissue availability, can we be your second tissue source?” (Second source agreements often become primary agreements; be ready when their tissue need arises.)

4) My hospital has a contract with another tissue bank…how can I bring in RTI tissue? Human tissue contracts are not 100% source agreements and are specific to the tissue bank. Ask to be a second source and define the specific differences between tissue processing. The BioCleanse® sterilization process is unique and therefore can lie outside of a contract. Understand the specific tissue types in the contract and offer to either bundle all biologics as a primary source or offer to second source for all biologics.

Ligament Toolkit  

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