Sacroiliac Joint Fusion Update Final Evidence Report May 17, 2021 Health Technology Assessment Program (HTA) Washington State Health Care Authority PO Box 42712 Olympia, WA 98504-2712 (360) 725-5126 www.hca.wa.gov/hta [email protected] Prepared by: RTI International–University of North Carolina Evidence-based Practice Center Research Triangle Park, NC 27709 www.rti.org This evidence report is based on research conducted by the RTI-University of North Carolina Evidence-based Practice Center through a contract between RTI International and the State of Washington Health Care Authority (HCA). The findings and conclusions in this document are those of the authors, who are responsible for its contents. The findings and conclusions do not represent the views of the Washington HCA and no statement in this report should be construed as an official position of Washington HCA. The information in this report is intended to help the State of Washington’s independent Health Technology Clinical Committee make well-informed coverage determinations. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients). This document is in the public domain and may be used and reprinted without permission except those copyrighted materials that are clearly noted in the document. Further reproduction of those copyrighted materials is prohibited without the specific permission of copyright holders. None of the individuals involved in producing this report reported any financial or non-financial conflicts of interest regarding the topic presented in this report. Acknowledgments The following individuals contributed to this report: Lead Investigator: Eva Chang, PhD, MPH Co-Investigators: Leila Kahwati, MD, MPH; Roberta Wines, MPH Project Coordinator: Rania Ali, MPH Analyst: Caroline Rains, MPH Scientific Reviewer: Meera Viswanathan, PhD Library/Document Preparation: Mark Howell, MLS; Loraine Monroe; Sharon Barrell, MA The following served as external peer reviewers of the draft version of this report and received an honorarium for this service. Peer reviewer comments and their disclosures of conflicts of interest are available at the State’s Health Technology Assessment Program’s website. https://www.hca.wa.gov/about-hca/health-technology-assessment/sacroiliac-joint-fusion. • William W. Cross, III, MD, Orthopedic Surgeon, Mayo Clinic, Rochester, MN • Bradley Weiner, MD, Vice Chairman of Orthopedic Surgery and Chief of Spine Surgery, Houston Methodist, Houston, TX WA – Health Technology Assessment May 17, 2021 Contents Contents ........................................................................................................................ i List of Appendices ........................................................................................................ ii List of Figures .............................................................................................................. ii List of Tables................................................................................................................ ii List of Abbreviations .....................................................................................................v Executive Summary .......................................................................................................... ES-1 Structured Abstract ........................................................................................................ ES-1 ES 1. Background ....................................................................................................... ES-3 ES 2. Methods ............................................................................................................. ES-4 ES 3. Results ............................................................................................................... ES-7 ES 4. Discussion ....................................................................................................... ES-17 ES 5. Conclusion ....................................................................................................... ES-22 Full Technical Report .............................................................................................................1 1. Background ................................................................................................................... 1 1.1 Condition Description .............................................................................................1 1.2 Disease Burden .......................................................................................................1 1.3 Technology Description ..........................................................................................2 1.4 Regulatory Status ...................................................................................................2 1.5 Policy Context ........................................................................................................7 1.6 Washington State Agency Utilization Data ..............................................................7 2. Methods ........................................................................................................................ 7 2.1 Research Questions and Analytic Framework ..........................................................7 2.2 Data Sources and Searches ......................................................................................8 2.3 Study Selection .......................................................................................................9 2.4 What is Excluded from This HTA ......................................................................... 12 2.5 Data Abstraction and Risk of Bias Assessment ...................................................... 12 2.6 Data Synthesis and Certainty of Evidence Rating .................................................. 13 3. Results ........................................................................................................................ 14 3.1 Literature Search ................................................................................................. 14 3.2 Sacroiliac Joint Fusion Compared to Conservative Management ........................... 16 3.3 Minimally Invasive Fusion Compared With Open Fusion ..................................... 31 3.4 Comparative Effectiveness of Alternative Minimally Invasive Fusion Procedures .. 36 3.5 Safety Outcomes from Uncontrolled Studies ........................................................ 40 3.6 Cost and Cost-Effectiveness .................................................................................. 43 3.7 Contextual Question ............................................................................................ 47 4. Discussion ................................................................................................................... 49 4.1 Summary of the Evidence ..................................................................................... 49 4.2 Limitations of the Evidence Base .......................................................................... 53 4.3 Clinical Practice Guideline Synthesis .................................................................... 55 4.4 Selected Payer Coverage Policies .......................................................................... 57 4.5 Limitations of This HTA....................................................................................... 64 4.6 Ongoing Research and Future Research Needs ...................................................... 64 5. Conclusion .................................................................................................................. 65 6. References ................................................................................................................... 66 Sacroiliac Joint Fusion Update: Final evidence report Page i WA – Health Technology Assessment May 17, 2021 List of Appendices Appendix A. State of Washington Health Care Authority Utilization Data ..............................A-1 Appendix B. Search Strategy ................................................................................................. B-1 Appendix C. Evidence Tables................................................................................................ C-1 Appendix D. Excluded Articles .............................................................................................D-1 Appendix E. Individual Study Risk of Bias Assessments ........................................................ E-1 List of Figures Figure ES-1. Analytic framework for HTA on sacroiliac joint fusion ................................. ES-5 Figure 1. Analytic framework for HTA on sacroiliac joint fusion ....................................... 8 Figure 2. Study flow diagram for the HTA update on sacroiliac joint fusion ..................... 15 Figure 3. Evidence map: sacroiliac joint fusion with iFuse compared to conservative management ..................................................................................................... 50 Figure 4. Evidence map: Open sacroiliac joint fusion compared to conservative management ....................................................................................................