Rotation Medical Initiates Post-Market Clinical Study Of Rotator Cuff Repair System With Bioinductive Implant
First patient enrolled and treated by Ted Schlegel, MD, at Steadman Hawkins Clinic in Denver –
Plymouth, MN – September 15, 2014 – Rotation Medical, a medical device company focused on developing new technologies to treat rotator cuff disease, today announced that it has initiated a multi-center post-market clinical study evaluating the use of the Rotation Medical rotator cuff system in treating supraspinatus rotator cuff tendon tears. The study will be conducted with leading orthopaedic and sports medicine surgeons across the U.S., including Ted Schlegel, MD, from Steadman Hawkins Clinic, Jeffrey Abrams, MD, from Princeton Orthopaedic Associates and Timothy Codd, MD, 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. “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.”
The study will evaluate tendon healing and growth of new tendinous tissue after the implantation of a Rotation Medical bioinductive implant that is used as either a standalone treatment for tendon tears or as an adjunct to surgical repair. Patients will undergo magnetic resonance imaging to assess post-operative changes in tendon thickness, tendon quality, and tear size. 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.
“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.”
Rotation Medical received 510(k) clearance from the Food and Drug Administration (FDA) for its implantable bioinductive implant technology in March 2014. The Rotation Medical rotator cuff system is commercially available in the United States.