Thomas W. Bauer

JBJS convened a symposium to discuss the reporting of sex and gender in research studies as an imperative to improve research methods and results to benefit all patients. Barriers to improved reporting include a lack of societal and cultural acceptance of its need; a lack of education regarding appropriate terminology and appropriate statistical methods and efficient study designs; a need for increased research funding to support larger group sizes; unknown concordance of cell and animal models with humans to reflect biologic variables such as sex; and a lack of understanding of key considerations of gender, race, and other social determinants of health and how these factors intersect. Attention to developing and disseminating best-practice statistical methods and to educating investigators (at all career levels), reviewers, funders, editors, and staff in their proper implementation will aid reporting. Concomitantly, well-designed studies with sufficient rigor and adequate resources are essential to enable meaningful and reproducible research. Existing recommendations, such as the Sex and Gender Equity in Research (SAGER) guidelines, provide valuable guidance that can be applied across the research ecosystem. Academic institutions and private foundations are likely groups to assist in scientific and institutional review board guidance and study recruitment and pilot funding to generate meaningful power estimates, and to serve as sources for additional funding and presentation of workshops, educational events, and seminars. All of this needs to be conducted on an ongoing basis to ensure that sex and gender are considered in scientific analyses, where relevant.

Case: A 66-year-old woman presented with shoulder pain and weakness 4 months after augmentation of a rotator cuff repair with a Stryker InSpace subacromial balloon spacer. A magnetic resonance imaging (MRI) demonstrated a failed rotator cuff repair, large effusion with rice bodies, synovitis, axillary lymphadenopathy, loose anchors, and erosive changes to the greater tuberosity. Arthroscopy revealed balloon fragmentation surrounded by diffusely hyperemic synovium without repairable cuff tissue. Final cultures proved negative for infection. Histologic evaluation revealed ulcerated synovium with diffuse chronic and focal acute inflammation. Conclusion: Despite promising early results, augmentation of a rotator cuff repair with a subacromial balloon spacer introduces a risk of inflammatory reaction that may mimic a deep infection and compromise rotator cuff healing.

Case: We present a delayed failure of an M6-C cervical disc arthroplasty after conversion of a subjacent failed cervical disc arthroplasty to fusion. The annular component had failed, and the core had been ejected. Histology demonstrated a giant cell reaction to polyethylene debris, and tissue cultures were positive for Cutibacterium acnes. Conclusion: This is the first report of M6-C failure after conversion of an adjacent arthroplasty to fusion. A growing number of reports surrounding the M6-C failure rate and mechanisms raise concern about the device's durability and underscore the importance of routine clinical and radiographic surveillance for these patients.

Case: A 65-year-old man with osteoarthritis of the hip developed a soft-tissue mass of the inferior gluteal region 3 years after metal-on-metal resurfacing hip arthroplasty. Clinical and imaging findings suggested an adverse local tissue reaction. Intraoperatively, nearly 1 liter of intra-articular fibrinous loose bodies (rice bodies) was removed, and histology showed features of an adaptive immune response. The patient had no evidence of an autoimmune disease or mycobacterial infection. Conclusion: To our knowledge, this is the first reported case of florid rice bodies associated with a metal-on-metal hip arthroplasty and adverse local tissue reaction.