Surgery vs. conservative care for meniscal tear after unsuccessful PT: an RCT

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The syndrome of knee pain and meniscal tear is prevalent in persons ≥ 45 years old, and associated with substantial pain, disability, and cost. Several randomized controlled trials (RCTs) have shown that initiating physical therapy (PT) in persons with this syndrome is associated with similar levels of pain relief as performing arthroscopic partial meniscectomy (APM). As a result, initial treatment with PT is now the standard of care. Those who do not respond to PT are often referred for APM, though there have been no trials of whether APM is efficacious in this setting. This planning grant lays groundwork for an RCT to address this important evidence gap. The study team at Brigham and Women’s Hospital (BWH) and University of Buffalo plans an RCT that enrolls persons with knee pain, meniscal tear and osteoarthritic changes into a run-in period in which subjects receive a standardized PT- based regimen. We will identify those with persistent pain despite PT and invite them to be randomized to either APM or a nonoperative regimen that includes intra-articular injections, an enhanced PT and exercise program, and additional support provided with web-based, telehealth, and face-to-face encounters with the research and clinical teams. We will assess pain relief and other outcomes over a two-year period. To prepare for the RCT, we apply for a planning grant with the following specific aims: • Finalize the operative and enhanced nonoperative regimen including choice of injection, specific exercise, and educational and support materials. • Assess and ensure physician equipoise for the two treatment strategies. • Estimate the number of eligible subjects/month and conduct model recruitment • Obtain Single IRB approval with BWH as governing IRB • Develop key study documents including clinical protocol, manual of operating procedures, safety monitoring and data monitoring and management plans, statistical analysis plan, recruitment and retention plan, and training/certification plans This planning grant will prepare the study team to launch an RCT that has the potential to change practice.