Arthrodesis of the ankle, hindfoot, and midfoot joints is an operative treatment for patients with severe pain or disability caused by arthritis, degenerative joint disease, trauma, congenital deformity, Charcot neuropathy, and other conditions. However, reported rates of nonunion following foot and ankle arthrodesis range from 0 to 36% with an average of 10 to 11%.

Nonunion following arthrodesis surgery is associated with poor function, disability, and the potential need for revision surgery. A number of factors have been reported to be associated with nonunion including patient factors, local factors at the site of surgery, and surgical factors.

Orthobiologics are biologically derived materials that may be used, in the context of arthrodesis, to promote bone formation and union at the arthrodesis site. Autograft, harvested from the iliac crest, tibia, calcaneus, or other sites, is considered the “gold standard” orthobiologic given that it possesses all 3 of the critical properties for bone healing: osteoconduction, osteoinduction, and osteogenesis.

Autograft has the advantages of minimizing risk of an immunologic response or infection that might occur with a donor product and is available at no cost (other than costs associated with harvesting the graft). However, the quantity of graft material is limited and there are potential complications, including the need for a separate incision site if a distant harvest site is chosen, longer operating time, nerve or vascular damage at the harvest site, and stress risers resulting in increased risk of bone fracture.

Other orthobiologic products have been considered for use in arthrodesis. Of interest for this review are non-structural products including osteoinductive products (eg, platelet-derived growth factor [PDGF], demineralized bone matrix [DBM], bone morphogenetic proteins [BMP], platelet-rich plasma [PRP]) and osteogenic products (eg, bone marrow aspirate [BMA]). Concerns with manufactured products include variability in manufacturing and differences across products in the same class due to proprietary preparation methods.

The purpose of our review was to examine the evidence from studies comparing use of an orthobiologic to no orthobiologic in primary foot (forefoot and proximally) and ankle arthrodesis procedures. Our focus was on non-structural autogenous orthobiologics.

Contents

• Preface
• Acknowledgments
• Executive Summary
  • Introduction
  • Methods
  • Results
  • Discussion
  • Abbreviations Table
• Introduction
• Methods
  • Topic Development
  • Search Strategy
  • Study Selection
  • Data Abstraction
  • Quality Assessment
  • Data Synthesis
  • Rating the Body of Evidence
  • Peer Review
• Results
  • Literature Flow
  • KEY QUESTION 1. What are the effectiveness and harms of adding orthobiologics compared to no orthobiologics when performing primary foot/ankle arthrodesis surgery?
  • KEY QUESTION 1A. Do effectiveness and harms vary by patient age, gender, smoking status, obesity, diabetes, bone quality, arthrodesis site, or use of medications that may impede healing (eg, immunosuppressives)?
  • KEY QUESTION 2. What is the cost and/or cost-effectiveness (as reported in the literature) of adding orthobiologics compared to no orthobiologics when performing primary foot/ankle arthrodesis surgery?
• Summary and Discussion
  • Key Findings
  • Discussion
  • Limitations
  • Applicability of Findings to the VA Population
  • Research Gaps/Future Research
  • Conclusions
• References
• APPENDIX A. Search Strategies
• APPENDIX B. Criteria Used in Quality Assessment
• APPENDIX C. Peer Reviewer Comments and Author Responses
• APPENDIX D. Evidence Tables

Suggested citation:

Example: Greer N, Yoon P, Majeski B, Wilt TJ. Orthobiologics in Foot and Ankle Arthrodesis Sites: A Systematic Review. Washington, DC: Evidence Synthesis Program, Health Services Research and Development Service, Office of Research and Development, Department of Veterans Affairs. VA ESP Project #09-009; 2020. Available at: https://www.hsrd.research.va.gov/publications/esp/reports.cfm.

This report is based on research conducted by the Evidence Synthesis Program (ESP) Center located at the Minneapolis VA Medical Center, Minneapolis, MN, funded by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development. The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of the Department of Veterans Affairs or the United States government. Therefore, no statement in this article should be construed as an official position of the Department of Veterans Affairs. No investigators have any affiliations or financial involvement (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in the report.