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Hip Resurfacing (Re-Review) 20, 2012 Health Technology Assessment Hip Resurfacing (Re-Review) Final Evidence Report October 14, 2013 Health Technology Assessment Program (HTA) Washington State Health Care Authority PO Box 42712 Olympia, WA 98504-2712 (360) 725-5126 hta.hca.wa.gov [email protected] Hip Resurfacing (Re-Review) Provided by: Spectrum Research, Inc. Prepared by: Joseph R. Dettori, PhD, MPH Robin Hashimoto, PhD Katie Moran, BS Erika Ecker, BS October 14, 2013 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 October 14, 2013 TABLE OF CONTENTS EXECUTIVE SUMMARY .......................................................................................................................1 1. APPRAISAL ................................................................................................................................... 10 1.1. RATIONALE ........................................................................................................................................ 10 1.2. KEY QUESTIONS ................................................................................................................................. 11 1.3. OUTCOMES ASSESSED ......................................................................................................................... 12 1.3.1. Efficacy and effectiveness measures ............................................................................................... 12 1.3.2. Minimum Clinically Important Difference (MCID) & Minimum Detectable Change (MDC) ............ 12 1.4. KEY CONSIDERATIONS HIGHLIGHTED BY CLINICAL EXPERTS: ......................................................................... 15 1.4.1. Intervention ..................................................................................................................................... 15 1.4.2. Costs ................................................................................................................................................ 16 1.4.3. Patient considerations..................................................................................................................... 16 1.4.4. Professional considerations............................................................................................................. 16 1.5. INCLUSION OF NON FDA-APPROVED DEVICES .......................................................................................... 16 1.6. WASHINGTON STATE UTILIZATION AND COST DATA .................................................................................. 17 2. BACKGROUND ............................................................................................................................. 24 2.1. HISTORY OF HIP RESURFACING ............................................................................................................. 24 2.2. POTENTIAL ADVANTAGES OF HIP RESURFACING VERSUS TOTAL HIP REPLACEMENT ....................................... 24 2.3. TARGET POPULATION .......................................................................................................................... 25 2.4. INDICATIONS FOR HIP RESURFACING ...................................................................................................... 25 2.5. CONTRAINDICATIONS FOR HIP RESURFACING ........................................................................................... 26 2.6. METAL-ON-METAL BEARINGS AND CURRENT SAFETY CONCERNS ................................................................. 26 2.7. POTENTIAL COMPLICATIONS/HARMS OF HIP RESURFACING ........................................................................ 27 2.8. IMPLANT DESIGNS ............................................................................................................................... 29 2.9. COMMON HIP RESURFACING DEVICES ..................................................................................................... 29 2.10. OPERATIVE APPROACH ........................................................................................................................ 30 2.11. CLINICAL GUIDELINES .......................................................................................................................... 31 2.11.1. National Guideline Clearinghouse ................................................................................................... 31 2.11.2. National Institute for Health and Clinical Excellence ...................................................................... 31 2.12. PREVIOUS SYSTEMATIC REVIEWS/TECHNOLOGY ASSESSMENTS .................................................................. 32 2.13. MEDICARE AND REPRESENTATIVE PRIVATE INSURER COVERAGE POLICIES .................................................... 39 3. THE EVIDENCE .............................................................................................................................. 43 3.1. METHODS OF THE SYSTEMATIC LITERATURE REVIEW ................................................................................ 43 3.1.1. Inclusion/exclusion .......................................................................................................................... 43 3.1.2. Data sources and search strategy ................................................................................................... 45 3.1.3. Data extraction ............................................................................................................................... 47 3.1.4. Study quality assessment: Class of evidence (CoE) evaluation ....................................................... 47 3.2. QUALITY OF LITERATURE AVAILABLE ...................................................................................................... 47 3.2.1. Number and quality of studies retained .......................................................................................... 47 3.2.2. Analysis ........................................................................................................................................... 47 3.2.3. Critical Appraisal (APPENDIX F) ....................................................................................................... 49 Hip Resurfacing (Re-Review): Final Evidence Report Page i WA - Health Technology Assessment October 14, 2013 4. RESULTS ...................................................................................................................................... 57 4.1. KEY QUESTION 1: WHAT IS THE EVIDENCE OF EFFICACY AND EFFECTIVENESS OF TOTAL HR COMPARED WITH THA? ............................................................................................................................................... 57 4.1.1. Efficacy ............................................................................................................................................ 57 4.1.2. Effectiveness.................................................................................................................................... 63 4.2. KEY QUESTION 2: WHAT IS THE EVIDENCE ABOUT THE SAFETY PROFILE FOR HIP RESURFACING COMPARED WITH THA? ....................................................................................................................................... 76 4.2.1. Revision ........................................................................................................................................... 77 4.2.1. Complications .................................................................................................................................. 82 4.2.2. Metal Ion Safety .............................................................................................................................. 85 4.3. KEY QUESTION 3: WHAT IS THE EVIDENCE OF EFFICACY, EFFECTIVENESS AND SAFETY OF REVISIONS OF HIP RESURFACING COMPARED WITH REVISIONS OF THA? ................................................................................ 93 4.4. KEY QUESTION 4: IS THERE EVIDENCE OF DIFFERENTIAL EFFICACY OR SAFETY ISSUES WITH USE OF HIP RESURFACING? ................................................................................................................................... 94 4.5. KEY QUESTION 5. WHAT IS THE EVIDENCE OF COST IMPLICATIONS AND COST EFFECTIVENESS OF HIP RESURFACING? ..................................................................................................................................
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