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Osteochondral Allograft/Autograft Transplantation (OAT) Health Technology Assessment

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Osteochondral Allograft/Autograft Transplantation (OAT) Health Technology Assessment WA Health Technology Assessment - HTA WASHINGTON STATE HEALTH CARE AUTHORITY Osteochondral Allograft/Autograft Transplantation (OAT) Health Technology Assessment Monday, October 17, 2011 Health Technology Assessment Program 676 Woodland Square Loop SE P.O. Box 42712 Olympia, WA 98504-2712 http://www.hta.hca.wa.gov WA Health Technology Assessment - HTA Osteochondral Allograft/Autograft Transplantation (OAT) Provided by: Spectrum Research, Inc. Prepared by: Andrea C. Skelly, PhD, MPH Erika D. Ecker, BS Jeannette M. Schenk‐Kisser, PhD, MS Barbara C. Leigh, PhD, MPH Annie Raich, MS, MPH With assistance from Robin E. Hashimoto, PhD Jeffrey T. Hermsmeyer, BA WA Health Technology Assessment: OATS (10-17-2011) Page 2 of 168 WA Health Technology Assessment - HTA This technology assessment report is based on research conducted by a contracted technology assessment center, with updates as contracted by the Washington State Health Care Authority. This report is an independent assessment of the technology question(s) described based on accepted methodological principles. The findings and conclusions contained herein are those of the investigators and authors who are responsible for the content. These findings and conclusions may not necessarily represent the views of the HCA/Agency and thus, no statement in this report shall be construed as an official position or policy of the HCA/Agency. The information in this assessment is intended to assist health care decision makers, clinicians, patients and policy makers in making sound evidence‐based decisions that may improve the quality and cost‐ effectiveness of health care services. Information in this report is not a substitute for sound clinical judgment. Those making decisions regarding the provision of health care services should consider this report in a manner similar to any other medical reference, integrating the information with all other pertinent information to make decisions within the context of individual patient circumstances and resource availability. WA Health Technology Assessment: OATS (10-17-2011) Page 3 of 168 WA Health Technology Assessment - HTA Table of Contents EXECUTIVE SUMMARY ................................................................................................ 7 Introduction ................................................................................................................................. 7 Key questions .............................................................................................................................. 8 Methods for evaluating comparative effectiveness .................................................................. 10 Results ....................................................................................................................................... 11 Summary by key question ......................................................................................................... 11 APPRAISAL ................................................................................................................. 25 Rationale ................................................................................................................................... 25 Objective ................................................................................................................................... 25 Key questions ............................................................................................................................ 25 Primary outcomes ..................................................................................................................... 26 Key considerations highlighted by clinical experts .................................................................. 27 Washington State utilization and cost data ............................................................................... 28 1. BACKGROUND ....................................................................................................... 32 1.1 The condition ...................................................................................................................... 32 1.2 The technologies and comparators ..................................................................................... 34 1.3 Clinical guidelines .............................................................................................................. 42 1.4 Previous systematic reviews/technology assessments ........................................................ 45 1.5 Medicare and representative private insurer coverage policies .......................................... 61 2. THE EVIDENCE ........................................................................................................ 67 2.1 Methods of systematic literature review ............................................................................. 67 2.2 QUALITY OF LITERATURE AVAILABLE ............................................................. 71 2.3 Description of study population .......................................................................................... 73 2.4 Description of study outcomes ........................................................................................... 77 3. RESULTS ................................................................................................................ 77 3.1 Key question 1: What is the case definition of a patient suitable for OATS/mosaicplasty surgery, and are there measures of reliability and validity for case identification? .............................................................................................................. 77 3.2 Key question 2: What are the expected treatment outcomes of OATS/mosaicplasty, and are there validated instruments and scores to measure clinically meaningful improvement? ........................................................................................ 89 WA Health Technology Assessment: OATS (10-17-2011) Page 4 of 168 WA Health Technology Assessment - HTA 3.3 Key question 3: What is the evidence of efficacy and effectiveness of OATS/mosaicplasty (open or arthroscopic)? .......................................................................... 104 3.4 Key question 4: What is the evidence of the safety of OATS surgery? ........................... 128 3.5 Key question 5: What is the evidence that OATS surgery has differential efficacy or safety issues in sub populations? .......................................................................... 142 3.6 Key question 6: What is the evidence of cost implications and cost- effectiveness for OATS/mosaicplasty? ................................................................................... 152 4. SUMMARY BY KEY QUESTION ............................................................................ 152 Summary of evidence and implications .................................................................................. 156 Remaining questions ............................................................................................................... 157 REFERENCES ............................................................................................................ 158 List of Tables Table 1. Summary of evidence for Key Question 1: Case Definition .......................................... 19 Table 2. Summary of Evidence for Key Question 2: Outcomes Measures .................................. 19 Table 3. Summary of Evidence for Key Question 3: Efficacy and Effectiveness ........................ 20 Table 4. Summary of Evidence for Key Question 4: Safety ......................................................... 22 Table 5. Summary of Evidence for Key Question 5: Differential efficacy, effectiveness and safety ............................................................................................................................................. 22 Table 6. Summary of Evidence for Key Question 6: Economic ................................................... 24 Table 7. Overview of previous technology assessments .............................................................. 47 Table 8. Overview of previous systematic reviews. ..................................................................... 50 Table 9. Overview of previous systematic reviews of talus osteochondral autograft transplantation (OATS), osteochondral allograft, or mosaicplasty .............................................. 60 Table 10. Overview of payer technology assessments and policies. ............................................ 63 Table 11. Summary of inclusion and exclusion criteria (PICO) ................................................... 67 Table 12. Summary of population, osteochondral defect and intervention characteristics for RCTs (or quasi-RCTs) comparing OAT/mosaicplasty (autograft) with other repair procedures 73 Table 13. Summary of population, osteochondral defect and intervention characteristics for case series reporting clinical outcomes following OATS using dowel-shaped allografts. ................... 75 Table 14. Treatment algorithm for focal chondral lesions (adapted from Cole, 2009)45 .............. 79 Table 15. Classification schemes for osteochondral defects that were used in the included comparative studies on knee repair ............................................................................................... 79 Table 16. Summary of inclusion/exclusion criteria from included RCTs of autograft OAT/mosaicplasty .......................................................................................................................
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