Touting a bevvy of orthopedic luminaries, Rotation Medical has begun a multi-center post-market clinical study evaluating the use of its rotator cuff system in treating supraspinatus rotator cuff tendon tears. Some of the orthopedic surgeons leading the effort 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.
“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 a Rotation Medical bioinductive implant (used as either a standalone treatment for tendon tears or as an adjunct to surgical repair). MRIs will be used to assess post-operative changes in tendon thickness, tendon quality, and tear size; each participant will be followed for two years postop. Shoulder function will be evaluated with the American Shoulder & Elbow Surgeons’ (ASES) Survey and Constant Shoulder Score.
“There are many limitations associated with the current standard of care for treating rotator cuff diseases and until this point, there has been no proven reproducible therapy to induce tendinous tissue and that has the potential to prevent the disease from progressing. As a consequence, many patients delay treatments, face lengthy rehabilitation or experience a high rate of re-tears, ” said Dr. Schlegel, lead investigator for the study. “This trial will add to the growing body of pre-clinical and clinical data evaluating the use of this bioinductive implant technology to improve healing at the tendon and bone interface with the goal of addressing these challenges.”
Dr. Schlegel told 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.”
He added, “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.”
