Vertebral Columns

Vertebral Columns International Society for the Advancement of Spine Surgery

Fall 2015

In This Issue

Editor in Chief Kern Singh, MD

EDITOR’S PERSPECTIVE

A New Era ................................................................1 ISASS POLICY UPDATES

ISASS joins AMA House of Delegates .....................3 POINT-COUNTERPOINT

Case Presentation .....................................................5 “MIS Lateral Approach is Best.................................6 “The Posterior Approach: Less is More...................7 Case Treatment ........................................................9 RESEARCH GRANTS

ISASS begins Research Grants Program.................10 NEW TECHNOLOGIES

Single Use Instruments Are Cost Effective in Spine Surgery: SafeOrthopaedics ..................................... 11

Editors Matthew Colman, MD Federico Girardi, MD Jeffrey Goldstein, MD Jonathan Grauer, MD Hamid Hassanzadeh, MD Safdar Khan, MD Choll Kim MD, PhD Martin Knight, MD, FRCS, MBBS Mark Kurd, MD Jean Charles Le Huec, MD, PhD Yu-Po Lee, MD Vikas Mehta, MD Isaac Moss, MD John O’Toole, MD Alpesh Patel, MD Sheeraz Qureshi, MD Kris Siemionow, MD Seth Williams, MD Publisher Jonny Dover

MEETING UPDATES

What you may have missed ..................................... 13 LITERATURE REVIEW

Highlights of Recent Spine Literature..................... 14 BUSINESS UPDATES

Motion in the Spine Industry.................................. 16 UPCOMING LITERATURE

Coming Soon to Journals Near You ........................18

Vertebral Columns is published quarterly by the International Society for the Advancement of Spine Surgery. © 2015 ISASS. Opinions of authors do not necessarily reflect positions taken by the Society. This publication is available digitally at http://vertebralcolumns.com.

EDITOR’S PERSPECTIVE

A New Era

by Kern Singh, MD Colleagues, welcome to the inaugural publication of Vertebral Columns, the official publication of our prestigious society. This enormous undertaking could not have been possible without the help of my esteemed partners on the publications committee and Jonny Dover for his tireless work on Society publications. I would also like to thank Gunnar Andersson, our copresident, for giving me the opportunity to lead this publication into the future.

Every quarter you will see fresh and controversial commentaries from distinguished leaders in the field of spine surgery. Hot topics, changes in reimbursement/coding, new technology, summary of recent journal publications, and scientific debates are only a few of the highlights from the upcoming issue. As always, we strive to be a publication that keeps our membership up to date with the events of the organization and would welcome any member to contribute to Vertebral Columns. I personally hope you find this publication to be insightful, thought provoking and refreshing. Our society has continued to grow and we need to continue that progress in order to make sure we are the DEFINITIVE society representing the views of our constituents‌the surgeons!

Now on to what I believe should be a focus of our society in the near future: more specifically, the changing economic environment of spinal healthcare delivery in the United States. The patient protection and affordable care act (2010) attempts to address this issue while improving the quality and access. Through provisions outlined in the law, direct endorsement by the president, and several demonstration projects, the bundled episode payment system has gained popularity as a means to contain healthcare-related costs.

EDITOR’S PERSPECTIVE

There is a spectrum of potential financial models for health care reimbursement. At one extreme is the fee-for-service model, which is currently the predominant model in the United States. This model limits the financial risk for providers. Healthcare providers are reimbursed for each discrete component of care that they provide, regardless of cost, quality, or outcome. On the opposite end of the spectrum is the concept of global payments. This is a capitation model in which a single amount is allocated for each episode of care independent of the extent of health-related needs. This model exposes providers to a substantial amount of financial risk in which the spine surgeon could be paid incrementally less depending on the utilization of resources.

The concept of bundled episode payments exists on a financial spectrum between the fee-for-service and global payment systems. In the bundled episode payment model, reimbursements occur for an entire episode of care. This model is most applicable to procedures in which a predetermined reimbursement could potentially be disbursed for the care episode and for any ancillary services provided over a predetermined time period. In this model, a single payment is given to providers to divide among services and materials. This single payment is intended to cover physician fees, operating costs, the inpatient stay, physical therapy following discharge, and any costs associated with complications or readmissions to the hospital.

The strongest theoretical advantage of the bundled payments is cost containment.

The incentives of all providers are aligned to reduce costs in order to share in the potential savings. This reduces the incentive for wasteful use of medical resources, especially those that may not significantly improve patient care. Bundled payments place greater incentive for providers to control avoidable and costly VERTEBRAL COLUMNS

complications during the postoperative period.

Critics would point out that a disadvantage of the bundled payment system is that hospitals and providers will unfairly select healthier patients or adjust indications of procedures in order to maximize profit. In addition, there are concerns that in an attempt to reduce costs, surgeons may favor cheaper, less technically complex procedures in replacement of more costly procedures that have demonstrated superior outcomes.

At this time, there is significant momentum to establish bundled payments as the primary means of reimbursement, particularly for elective procedures with well-defined outcomes and consistent involvement of particular ancillary services. This is especially attractive for common, elective orthopedic and spine procedures.

The financial implications of bundled payments for surgeons are significant. For example, surgeons would clearly take on greater financial risk. Such risk has two components. The first is probability risk, which refers to random events that occur as a result of uncontrollable external and genetic factors related to the patient. The second is technical risk, which refers to risk that is a direct consequence of the intervention and care during the episode.

These risks include postoperative complications, urinary tract infections, and readmissions. In an ideal system, any penalties to providers should relate to technical risk; however, the distinction between technical risk and probability risk is not always defined. For instance, the impact of factors such as patient nonadherence to medical and therapeutic regimens, preoperative illness severity, and poor patient lifestyle choices is hard to dichotomize clearly into either of the two classifications. The providers will inevitably take on at least a proportion of 1

this risk as it not only difficult to clearly define them, but would be administratively unfeasible to do so.

The increased financial risk undertaken by surgeons will need to be offset with the potential for larger financial gains. In order to protect providers, a proper risk corridor must be established. A risk corridor limits the profits and losses above or below a given percentage from the net neutral position. By defining the range of profits and losses, surgeons are protected from catastrophic financial losses while any exuberant gains are limited.

In the context of the increasing demand for cost control in spine surgery, recent trends have emerged. One such trend is the movement towards performing surgery in ambulatory surgery centers (ASC). ASCs aim to avoid the expensive costs of

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hospitalization, which have historically been one of the largest contributors to the total cost of a care episode. The shift towards ASCs increases the predictability of the related costs while reducing the potential of developing costly complications during a hospital admission.

In addition, criticism regarding the use of implants and biologics may increase as their utilization have been the source of increasing costs. There will be more discretion regarding the use of newer, more costly designs that may only benefit marginally over traditional options.

Procedures such as a simple decompression for stable degenerative conditions may also gain popularity in place of a more costly fusion procedure if the reimbursements within the bundled payment for both types of procedures are comparable.

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The specifics of when the changes to the health care system will occur and how they will impact surgeons’ practices remain unclear. However, the fact that the healthcare system is changing has never been more certain. All surgeons should anticipate these changes and be active participants in the discussion in order to properly advocate what is best for their patients and their respective specialties.

The shift in payment systems should be a beckoning call for surgeons to unite their interests in order to clearly establish the value of their services to the hospital and the society at-large. With this rapidly changing future in spine surgery upon us, the onus is for us as the surgeon to support our society and to advocate for our patients. We are the caregivers for spinal health care and we should be defining our future for the betterment of our patients.

EDITOR’S PERSPECTIVE

ISASS POLICY UPDATES

ISASS joins AMA House of Delegates

by Liz Vogt, Director of Health Policy and Advocacy ISASS attended the American Medical Association (AMA) annual meeting June 6-10 in Chicago. After a three-year process to obtain a voting seat, ISASS became a voting member of the AMA’s House of Delegates (HOD) in 2014. The HOD is the legislative and policy-making body of the AMA and includes over 500 voting delegates selected by their member organizations to establish broad policy on health, medical, professional and AMA governance issues. Members of the HOD include state medical associations, the five federal services (US Air Force, US Army, US Navy, US Department of Veterans Affairs and US Public Health Service), national medical specialty societies and professional interest medical associations, sections and groups. ISASS is considered a national medical specialty society in the HOD and participates in the Specialty and Service Society (SSS) Caucus, the largest caucus in the HOD. Gunnar B.J. Andersson, MD, PhD serves as the ISASS delegate to the HOD and Morgan Lorio, MD, FACS serves as the ISASS alternate delegate to the HOD.

for the October 1, 2015 implementation deadline, the AMA HOD adopted a policy supporting a two year grace period during which physicians will not be penalized for errors, mistakes and or malfunctions related to adjusting to new ICD-10 coding specifications. The AMA will be asking federal officials to support legislative efforts establishing the twoyear grace period.

• Ending non-medical exemptions for immunization and implementing education efforts to encourage vaccinations • Preventing fire-arm related injury in youth • Immunity from Federal prosecution for cannabis prescribing physicians • Issues related to maintenance of licensure and certification • Ethical practice in telemedicine • Pricing of prescription drugs • Obesity education • Concussion in youth sports • Preventing violent acts against healthcare providers

• Three Day Stay Rule • Recreational use and abuse of prescription drugs ISASS is excited to participate in this policy-making forum — policies developed and adopted by the HOD drive AMA advocacy efforts in D.C., state capitols, and the commercial health care market. It is important for ISASS to have a seat in the AMA HOD to: • increase our legitimacy and credibility within the orthopaedic community, throughout the wider medical society world and within the entire health care arena; • enhance our policy and advocacy goals and brings the voice of the spine surgeon into the larger policy debate on healthcare; • provide our society with an official voice as an advisor to the CPT Editorial Panel, and as a representative to the CPT Relative Values Update Committee (the RUC). As new technologies and procedures emerge in spine, we must have

This year, over 200 reports and resolutions were introduced for consideration by the HOD, however not all introduced resolutions were adopted as policy. The HOD can vote to adopt resolutions, amend resolutions, refer resolutions to the Board of Trustees for further study or for decision, or choose not adopt certain resolutions.

Some of the hot-button issues at this year’s meeting include: • ICD-10 - The AMA has historically been opposed to the implementation of ICD-10, but recognizing that many of its members have invested a significant amount of time and resources preparing

ISASS POLICY UPDATES

Welcome to the Table! ISASS takes a seat at the AMA House of Delegates. Photo credit Liz Vogt.

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a seat at the table when CPT codes are created or modified, and when CPT codes are valued through the RUC process; and • give our society a seat within the AMA Physician’s Consortium for Performance Improvement (the Consortium). The Consortium is one of the leading bodies driving the development of performance measures that are increasingly being used

by Medicare, Medicaid and commercial health insurers to improve physician

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performance and to modify physician payment in accordance with adherence to recognized measures. As performance measures are developed with regard to spine, it is critical that ISASS is leading this effort.

To that end, we suggest you submit a letter to your members of Congress at https://www.votervoice.net/AMA/campaigns/41309/respond.

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The AMA HOD will convene again at its interim meeting November 14-17 in Atlanta. ISASS will be in attendance to represent the interests of our members. If you have any questions, need additional information regarding the AMA HOD, or would like to get more involved in ISASS policy and advocacy efforts, please contact Liz Vogt, Director of Health Policy and Advocacy for ISASS and IASP.

ISASS POLICY UPDATES

POINT-COUNTERPOINT

Case Presentation A 70-year-old female with a history of L4-5 laminectomy for stenosis 9 years prior (from which she did well) presents with 2 years of progressively worsening low back and left leg pain in an L4 distribution.

Standing and walking tolerance are reduced to 5 minutes and 1 block, respectively. Her symptoms have worsened despite 2 months of physical therapy and 3 epidural steroid injections (including left L4 selective nerve root block that gave 2 weeks of relief of leg pain). Her ODI is 58%, VAS back is 8/10 and VAS leg is 6/10.

Notable findings on physical examination include a normal stance with no gross anatomic imbalance, left leg antalgia with ambulation, decreased sensation in the left L4 distribution and normal motor strength throughout.

Imaging studies including upright dynamic lumbar radiographs, lumbar MRI and lumbar CT are shown (figures 1-5) and reveal postoperative changes of L4-5 laminectomy, bilateral L4 spondylolysis, L4-5 grade 2 spondylolisthesis, left greater than right L4-5 foraminal stenosis and severe L4-5 disc degeneration with vacuum disc and sclerotic endplates. There has been clear progression in the degree of spondylosis and spondylolisthesis (from grade 1 to grade 2) since imaging 2 years prior. There is no sagittal imbalance on 36 inch standing films (not shown).

Figure 1. Upright AP (A) and lateral (B) radiographs of the lumbar spine.

POINT-COUNTERPOINT

What is the optimal surgical approach for the management of this patient?

In particular, would a minimally invasive lateral interbody fusion or a posterior fusion be preferable?

Figure 2. Upright extension (A) and flexion (B) radiographic view of the lumbar spine.

Figure 3. MRI views of the lumbar spine: (A) midline sagittal STIR image; (B) midline sagittal T2-weighted image; and T2-weighted parasagittal right (C) and left (D) images.

Figure 4. Serial T2-weighted axial MRI images at the L4-5 level.

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Figure 5. Sagittal reconstructions of lumbar spine CT in the midline (A) and right (B) and left (C) parasagittal regions.

“MIS Lateral Approach is Best�

by Yu-Po Lee, MD and Juan S. Uribe, MD Lateral interbody fusion with percutaneous pedicle screws would be the ideal treatment for this interesting and commonly encountered case. Many options can be considered here. Open posterior decompression and instrumented fusion with iliac crest bone graft has been described as early as 1946 as a treatment for lumbar stenosis and spondylolisthesis.1 Over the years, the results have been very good. However, after 70 years of scientific and technological advancements, we must ask ourselves if this is still the best treatment for lumbar stenosis and spondylolisthesis.

In this case, the goals of this surgery are adequate decompression of the nerves, correction of deformity, stability to prevent progression of the spondylolisthesis, and fusion to provide long-term relief. Lateral interbody fusion is a superior method of achieving all of these results compared to traditional open posterior decompression and fusion. In a study by Khajavi et al., the authors performed a retrospective review on 60 patients who underwent a lateral 6

interbody fusion for symptomatic lumbar stenosis and spondylolisthesis.2 The authors found that at 1 year, low back pain improved 71 %, leg pain improved 68 %, and a substantial clinical benefit was met by 94.7% of those patients. Also, they found that foraminal height, width, and volume increased 19.7, 18.0, and 39.6 %, respectively. That is a key point in this argument because the majority of the stenosis in this case is in the neuroforamen.

In addition, the authors found that segmental lordosis increased 27.8%. The main benefits of an interbody are the indirect decompression of the neuroforamen and the ability to improve segmental lordosis. This is very difficult to do with posterior instrumentation alone across a single segment.

In another paper by Rodgers et al., the authors performed a review of 600 patient who underwent a lateral interbody fusion.3 In the study, the average hospital stay was 1.21 days and there were no wound infections, no vascular injuries, no intraoperative visceral injuries, and 4 (0.7%) transient postoperative neurologic deficits. The merits of open versus minimally invasive surgery have been VERTEBRAL COLUMNS

debated since minimally invasive spine surgery started. Over time, while the longterm results are very similar, the trend is that minimally invasive spine surgery does result in a shorter hospital stay with a smaller risk of infections and other complications. In a study by Kalanithi et al., the authors reviewed the Nationwide Inpatient Sample (NIS) administrative data from 1993 to 2002.4 From a database of 66,601 patients who had an open decompression and posterior instrumented fusion for lumbar stenosis and spondylolisthesis, the authors noted a mortality rate of 0.15%. Also, 11% of patients had one or more in-hospital complications with hematoma/seroma (5.4 per 100) being the most common complication. With this being a revision case, I would expect that risk to be even higher.

The long-term results of lateral interbody fusion are also very encouraging. In a study

by Castellvi et al., the authors performed a prospective study on 158 patients.5 As expected, VAS pain scores and ODI both improved (p < 0.001) at 3 months and were maintained at 1 year. The authors also performed CT scans on these patients after POINT-COUNTERPOINT

1 year and found 100% solid fusions.

Another added benefit of the interbody cage is improved fusion rate. In a study by Liu et al., the authors performed a large meta-analysis posterior lumbar interbody fusions versus posterior instrumented fusions.6 The authors found moderatequality evidence indicating that the interbody improved fusion rates.

Prior to choosing a particular surgical technique, approach-related risks and potential complications should be considered. Posterior approaches involve extensive muscle dissection and removal of posterior elements, which can further compromise spinal stability. The MIS lateral approach to the L4-5 interspace can be safely accessed by controlling direction, extent and time of retraction of critical neuromuscular structures by: 1) understanding the lumbar plexus anatomy, 2) meticulous surgical technique, 3) adequate identification of the main motor branches of the lumbar plexus using directional EMG monitoring that allows placement and docking the expandable tubular retractor anterior to the femoral nerve and 4) gentle neuromuscular retraction by limiting retractor opening and timely mobilization of the femoral nerve from anterior to posterior.7-11 Hence, lateral interbody fusion is the superior procedure for this patient. The lateral interbody fusion provides the patient with a very good indirect decompression. The added benefits in this case are that the patient will have the same outcome as an open posterior

decompression and fusion but with a much shorter hospital stay and a much lower risk of infection and other complications. In addition, the long-term results may be better. Fusion rates have been shown to be better with an interbody cage and so her risk of having revision surgery for pseudoarthrosis will be less. Also, her segmental lordosis will be better with an interbody cage. While we are still determining the long-term benefits of improved segmental lordosis, the trend in the literature is that patient outcomes are superior with improved sagittal alignment.12 So clearly in this case, “less is more.”

References 1. Spray PE, Ghormley RK. Results in a case of spondylolisthèsis eight years after spinal fusion. Proc Staff Meet Mayo Clin.

1946 Apr 3;21:150.

2. Khajavi K, Shen A, Hutchison A. Substantial clinical benefit of minimally invasive lateral interbody fusion for degenerative spondylolisthesis. Eur Spine J. 2015 Mar 24.

3. Rodgers WB, Gerber EJ, Patterson JR. Intraoperative and early postoperative complications in extreme lateral interbody fusion (XLIF): An analysis of 600 cases.

Spine (Phila Pa 1976). 2011 Jan 1;36(1):26-32.

4. Kalanithi PS, Patil CG, Boakye M. National complication rates and disposition after posterior lumbar fusion for acquired spondylolisthesis. Spine (Phila Pa 1976).

2009 Aug 15;34(18):1963-9 5. Castellvi AE, Nienke TW, Marulanda

“The MIS lateral approach to the L4-5 interspace can be safely accessed by controlling direction, extent and time of retraction of critical neuromuscular structures”

GA, et al. Indirect decompression of lumbar stenosis with transpsoas interbody cages and percutaneous posterior instrumentation. Clin Orthop Relat Res. 2014 Jun;472(6):1784-91.

6. Liu X, Wang Y, Qiu G, et al. A systematic review with meta-analysis of posterior interbody fusion versus posterolateral fusion in lumbar spondylolisthesis. Eur Spine J. 2014 Jan;23(1):43-56.

7. Minimally invasive lateral retroperitoneal transpsoas interbody fusion for L4-5 spondylolisthesis: clinical Ahmadian A, Verma S, Mundis GM Jr, Oskouian RJ Jr, Smith DA, Uribe JS. J Neurosurg Spine. 2013 Sep;19(3):314-20.

8. Analysis of lumbar plexopathies and nerve injury after lateral retroperitoneal transpsoas approach: diagnostic standardization. Ahmadian A, Deukmedjian AR, Abel N, Dakwar E, Uribe JS. Neurosurg Spine. 2013 Mar;18(3):289-97.

9. Postoperative lumbar plexus injury after lumbar retroperitoneal transpsoas minimally invasive lateral interbody fusion.

Le TV, Burkett CJ, Deukmedjian AR, Uribe JS. Spine (Phila Pa 1976). 2013 Jan 1;38(1):E13-20 10. Electromyographic monitoring and its anatomical implications in minimally invasive spine surgery. Uribe JS, Vale FL, Dakwar E.Spine (Phila Pa 1976). 2010 Dec 15;35(26 Suppl):S368-74.

11. Defining the safe working zones using the minimally invasive lateral retroperitoneal transpsoas approach: an anatomical study. Uribe JS, Arredondo N, Dakwar E, Vale FL.J Neurosurg Spine.

2010 Aug;13(2):260-6.

12. Kim MK, Lee SH, Kim ES, et al. The impact of sagittal balance on clinical results after posterior interbody fusion for patients with degenerative spondylolisthesis: a pilot study. BMC Musculoskelet Disord. 2011 Apr 5;12:69.

“The Posterior Approach: Less is More”

by Wellington K. Hsu, MD

POINT-COUNTERPOINT

The treatment of lumbar degenerative spondylolisthesis is complex in the sense

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that no two patients are alike. Although this a common symptomatic condition that

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leads to both back and leg pain, the decision-making process is critically affected by patient demographics such as age and activity level, comorbidities, and ultimate goals of the procedure. Surgeons should adopt an algorithm that takes all patient and surgical factors into account as the one-size-fits-all approach can lead to an inefficient use of resources.

For this particular case, in an elderly female with neurogenic claudication and a presumed iatrogenic grade 2 degenerative spondylolisthesis after laminectomy, after failure of conservative management, the evidence-based literature suggests that she would be a strong candidate for a revision lumbar decompression and fusion at L4-5.

Perhaps the most well-designed study that can guide our decisions come from the Spine Patient Outcomes Reported Trial, where 591 patients were prospectively followed after nonoperative versus operative treatment for degenerative spondylolisthesis1. We have learned many things from the body of evidence from this research effort including risk factors for SSI, predictors of outcome, and benefits of using interbody devices, to name a few.2-4 The literature suggests that a revision decompression and fusion for this particular patient from a posterior approach may be the most cost-effective and efficacious way to improve this patientâ&#x20AC;&#x2122;s quality of life, especially when compared to a lateral interbody approach5.

While some studies demonstrate a marginal benefit with the use of interbody devices to increase fusion rates, there has been no published literature that reveals a difference in clinical outcomes when this technology is used. Furthermore, in a 70-year old female, the addition of interbody instrumentation may be unnecessary as studies that utilize posterior fixation alone in this patient population is adequate. The level of foraminal stenosis makes a posterior decompression a bit more challenging, however, a direct approach to this pathology may provide a more effective assessment of the neurologic compromise as opposed to an indirect one (lateral interbody).

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While there are a number of alternative surgical procedures that could lead to adequate clinical outcomes, one must keep in mind the relative risks of each including those of a lateral interbody approach. This novel technique has vastly improved our ability to tackle degenerative scoliosis curvatures through a minimally invasive incision, however, our particular case does not involve that pathology. The lateral approach has been associated with a number of complications including lumbar plexus injury, groin/hip pain, leg weakness, and even death.6,7 The incidence of these adverse events appears to increase at the level of L45, which is the location of pathology for this patient. While a lateral interbody spacer could greatly improve the disc height at L4-5, there is no evidence to suggest that this metric would improve any clinical outcomes. One must consider weighing the risks and benefits of any surgical procedure before proceeding in an elderly patient.

To conclude, while there are often many different surgical procedure that will lead to good clinical outcomes in patients with degenerative spondylolisthesis, a one-sizefits-all approach may be irresponsible to the breadth and variety of people that require our services. For this elderly patient with a symptomatic degenerative spondylolisthesis at L4-5, I believe that a decompression and fusion from posterior approach only offers her the greatest opportunity at an excellent clinical outcome without exposure to unnecessary risk.

â&#x20AC;&#x153;a one-size-fits-all approach may be irresponsible to the breadth and variety of people that require our servicesâ&#x20AC;?

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References 1. Pearson A, Blood E, Lurie J, Abdu W, Sengupta D, Frymoyer JW, Weinstein J. Predominant leg pain is associated with better surgical outcomes in degenerative spondylolisthesis and spinal stenosis: results from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2011;36:219-29.

2. Pearson A, Lurie J, Tosteson T, Zhao W, Abdu W, Weinstein JN. Who should have surgery for spinal stenosis? Treatment effect predictors in SPORT. Spine (Phila Pa 1976). 2012;37:1791-802.

3. Rihn JA, Radcliff K, Hilibrand AS, Anderson DT, Zhao W, Lurie J, Vaccaro AR, Freedman MK, Albert TJ, Weinstein JN. Does obesity affect outcomes of treatment for lumbar stenosis and degenerative spondylolisthesis? Analysis of the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976).

2012;37:1933-46.

4. Gottschalk MB, Premkumar A, Sweeney K, Boden SD, Heller J, Yoon ST, Rhee JM, Leckie SK, Braly B, Simpson AK, Lenehan E. Posterolateral Lumbar Arthrodesis With and Without Interbody Arthrodesis for L4-L5 Degenerative Spondylolisthesis: A Comparative Value Analysis. Spine (Phila Pa 1976).

2015;40:917-25.

5. Fujimori T, Le H, Schairer WW, Berven SH, Qamirani E, Hu SS. Does Transforaminal Lumbar Interbody Fusion Have Advantages over Posterolateral Lumbar Fusion for Degenerative Spondylolisthesis? Global Spine J. 2015;5:102-9.

6. Assina R, Majmundar NJ, Herschman Y, Heary RF. First report of major vascular injury due to lateral transpsoas approach leading to fatality. J Neurosurg Spine.

2014;21:794-8.

7. Isaacs RE, Hyde J, Goodrich JA, Rodgers WB, Phillips FM. A prospective, nonrandomized, multicenter evaluation of extreme lateral interbody fusion for the treatment of adult degenerative scoliosis: perioperative outcomes and complications.

Spine (Phila Pa 1976). 2010;35:S322-30.

POINT-COUNTERPOINT

Case Treatment The patient underwent a L4-5 MIS lateral transpsoas interbody fusion from the left hand side with placement of a 22mm wide, 11mm tall and 12 degree lordotic spacer packed with morcellized allograft supplemented with bone marrow aspirated from the iliac crest through the same lateral incision. At the same sitting, she was turned prone and percutaneous pedicle screws were inserted at L4-5 (figure 6).

Total OR time was 130 minutes, blood loss was 15 cc and the patient was discharged home on POD #2. At 1 year follow-up, she had returned to normal activities and her ODI was 22%, VAS back was 2 and leg was 0.

Figure 6. Postoperative upright AP (A) and lateral (B) lumbar spine radiographs.

POINT-COUNTERPOINT

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RESEARCH GRANTS

ISASS begins Research Grants Program Seeking Applicants and Donors ISASS is seeking applicants and donors for our new Research Grants program. The ISASS Research Grants program was developed by the ISASS Research Committee to address the need for research in areas of spine surgery that answer questions important to improving patient care yet go unfunded for various reasons.

ISASS is an international organization.

Applicants in the spine surgery specialty from any location are qualified to apply for a grant or fellowship. Local grant regulations may apply and must be evaluated by the applicant prior to submitting an application. Applicants must be ISASS members.

Applicant Guidelines & How to Apply »

Your support for ISASS Research projects is needed and your contribution will be greatly appreciated. There are two funds that donors may choose. For both funds, 100% of donations are applied to unbiased, independent research focusing on the advancement of spine surgery.

ISASS Research Fund The ISASS Research Fund collects donations to support research projects each year from applications selected by the ISASS Research Committee. The ISASS Research Fund will be used to support basic and applied clinical science focusing on the advancement of spine surgery.

ISASS Research Grants Website » ISASS Research Grants support basic and applied clinical science research focusing on the advancement of spine surgery for improved patient care. 100% of donations are applied to unbiased, independent research focusing on the advancement of spine surgery. ISASS Research Grants fund research that is not directly undertaken by corporate or other profitseeking entities due to issues with commercial viability or conficts of interest but answer important questions for the spine surgery specialty.

ISASS Research Endowment Fund To ensure future funding, ISASS has developed the ISASS Research Endowment Fund. Donations to this Fund are applied as needed to grants that exceed funds available via the ISASS Research Fund.

ISASS grants are awarded to applications selected by the ISASS Research Committee to qualified spine surgery specialists. These grants are funded by tax deductible donations to the ISASS Research Fund and the ISASS Spine Research Endowment Fund.

100% of Donations Are Directly Applied to Research Projects Your completely tax deductible donation (US and other countries) to either of the ISASS Research Grant funds will enable us to fund vital research that is necessary to further the advancement spine surgery for improved patient care. There is a critical need for unbiased, independent research and ISASS is dedicated to funding these worthwhile grants but needs your help! Your total donation will go to research. ISASS dedicates 100% of the donations directly to funding research projects.

Information for Applicants ISASS offers research grants and young investigator grants in the categories of clinical and basic science. The number and amount of awards each year is determined by the funds collected and the approval of the specific applications by the ISASS Research Committee. Recommendations are forwarded to the Research Council and then to the Executive Committee for approval.

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Information for Donors

Make a Donation Today »

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RESEARCH GRANTS

NEW TECHNOLOGIES

Single Use Instruments Are Cost Effective in Spine Surgery: SafeOrthopaedics

by Jean Charles Le Huec, MD, Jeffrey Goldstein, MD, Antonia Faundez, MD, & Mark F. Kurd, MD Over the past fifty years, innovation has driven the evolution of orthopedic and spinal implant technologies. Sophisticated instrument and implant systems have achieved broader indications, better outcomes and shorter operative times.

However, this evolution has also yielded increased complexity and cost, running contrary to the realities of today’s healthcare economic challenges. The need for more cost effective, safe and efficient surgical systems is driving a new wave of innovation that extends beyond the operating theatre.1-4 It is interesting to consider the current model for preparing an orthopedic set for surgery. Sets are delivered from a sales representative’s car or via overnight delivery from an industry loaner facility.

The hospital then assumes responsibility, cost and risk, associated with getting the set “surgery ready.” The cost and burden associated with these processes have forced many hospitals to outsource these activities.5 Upon completion of the surgical procedure, the burden continues. Postoperative cleaning and decontamination is required to prepare the set for the next surgery, or for return to the manufacturer.

There is a real concern about safety in the current model of field replenishments, minimal quality control of instruments and lack of viable traceability programs leading to significant risk for the hospital, surgeon and patient. These deficiencies are receiving increased scrutiny from regulatory authorities around the globe.

Implementation of Unique Device Identification (UDI) standards is now a question of “when” rather than “if.”

European measures issued by NEW TECHNOLOGIES

Commissioner John Dalli in February 2012 are moving quickly toward defined requirements for implant traceability. The challenges of cross-contamination are also a priority for surgeons and hospitals. The risk of improperly cleaned and sterilized tools has been exacerbated by the emergence of highly complex instrumentation, often provided without dismantling and cleaning instructions.

Such clear deficiencies in the existing model beg industry for answers, and inevitably they emerge. SafeOrthopaedics, LLC presents a complete lumbar pedicle screw system including interbody cages in lightweight, sterile, traceable and singleuse surgical kits.

The Sterispine PS and Sterispine LC systems from SafeOrthopaedics include single-use instruments commonly used in pedicle screw and interbody cage placement (Figures 1-3). The screws and cages are individually packaged and are preloaded with a screwdriver or inserter.

Similar to traditional systems on the market, a range of sizes for both the screws and cages are available. Screws are canulated and double-threaded and cages are available for both posterior lumbar and transformanial lumbar interbody fusions (PLIF and TLIF). The set of instruments and implants for a single level lumbar fusion weighs 2kg (4 lbs). Since the system is sterilely packaged, the technology is surgery-ready at a moments notice. The versatile instrument kit can accommodate open and minimally invasive surgical techniques for screw and cage insertion.

Instruments are made of IXEF, which is a polyacrylamide (PARA) with 50% glass fibers, minerals, and other additives. IXEF properties include high strength and stiffness, lightweight, creep resistant at high stress levels, dimensional stability, and brilliant aesthetics. These products are VERTEBRAL COLUMNS

processed on conventional injection molding equipment. IXEF is well suited for medical applications because the manufacturing process has excellent repeatability and allows the creation of complex, thin shapes. The material is gamma compatible and has tensile and flexural strength similar to many metals and alloys.

There are no published studies evaluating the potential benefits of the

Figure 1. Canulated screws with screw extenders pre-mounted and ready to use with the screw driver in place.

Figure 2. Disposable instruments provided to perform the surgery.

Figure 3. Disposable isntruments provided for disc preparation and cage insertion.

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