Rotation Medical has officially begun a multi-center post-market clinical study evaluating the use of the Rotation Medical rotator cuff system in treating supraspinatus rotator cuff tendon tears. Involved in the study on this 510(k) cleared device are Ted Schlegel, M.D., from Steadman Hawkins Clinic, Jeffrey Abrams, M.D., from Princeton Orthopaedic Associates and Timothy Codd, M.D., from Towson Orthopaedic Associates/University of Maryland Medical System, among others.
Rotation Medical Commences Study on Rotator Cuff Tendon Tears
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“We are pleased to conduct this important research with these well respected and accomplished thought leaders, ” said Martha Shadan, CEO and president of Rotation Medical, in the September 15, 2014 news release. “The information that we gain from this post-market clinical trial will expand the body of evidence documenting the value of the Rotation Medical technology and advance our mission to provide relief for patients by reversing rotator cuff disease progression and restoring long-term shoulder function.”
Patients will be implanted with the company’s bioinductive implant and will be assessed as for tendon healing and growth of new tendinous tissue. Each participant will have an MRI to assess post-operative changes in tendon thickness, tendon quality, and tear size. According to the news release, “Researchers will also evaluate shoulder function using the American Shoulder & Elbow Surgeons’ (ASES) Survey and Constant Shoulder Score and analyze recovery outcomes including sling time, return to work, and physical rehabilitation. Study patients will be followed for two years after surgery.”
Dr. Schlegel commented to OTW, “With this post market study, we seek to build on the body of clinical evidence evaluating the use of the Rotation Medical rotator cuff system in humans. Studies have shown the ability of this technology to induce the growth of new tendinous tissue. This clinical study will enable us to further explore this and better understand the clinical outcomes implications associated with this technology. Within a year, we hope to have enrollment completed and plan to submit study results for publication. In addition, I expect that we will have significant experience using this technology in clinical practice to help patients suffering from rotator cuff disease.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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