Rotator Cuff specialist, Rotation Medical Inc., is touting study results showing that the company’s collagen-based bioinductive implant induced new tissue formation in all study patients with rotator cuff tears.
Background
While it’s now commonplace to treat degenerate or torn rotator cuffs, outcomes can be adversely affected due to the relatively poor quality of the underlying tendon tissue. As a consequence, a significant number of repaired tendons will either degenerate further and/or re-tear. Cleared by the U.S. FDA in March 2014, the Rotation Medical bioinductive implant is designed to address this limitation by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly.
Published in the current issue of Muscles, Ligaments and Tendons Journal, the newly announced study assessed the ability of Rotation Medical’s bioinductive implant to induce new tissue formation and limit tear progression when placed on the bursal surface of partial thickness cuff tears. Entitled “Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up,” the company claims it adds to the growing body of literature supporting the use of the bioinductive implant as a novel treatment for rotator cuff partial thickness tears.
A total of 13 patients with intermediate (3-6 mm) to high-grade (>6 mm) partial thickness cuff tears completed two years of follow-up. At three, six, 12, and 24 months postoperatively, tendon thickness, defect size and quality were evaluated using magnetic resonance imaging (MRI), and clinical outcomes were assessed using the Constant and American Shoulder and Elbow Society scores.
The partial-thickness cuff tears showed consistent filling of the defects, with complete healing in seven patients at 12 months, and a progressive improvement in tendon quality in the remaining patients. No tear progression was observed by MRI in any of the patients at 24 months. All clinical scores improved significantly over time. At 24 months, 12 of 13 patients (92 percent) had satisfactory or better results.
The implant appeared to have induced significant new tissue formation in all 13 patients by three months (mean increase in tendon thickness 2.2 ± 0.26 mm), and the tissue matured over time and became radiologically indistinguishable from the underlying tendon. No tear progression was observed on MRI in any of the patients during the 24-month post-operative period. All the patients’ Constant and American Shoulder and Elbow Society clinical scores improved significantly over time.
Investigator comments
“Partial-thickness rotator cuff tears frequently enlarge due to increased local strain and often progress to full-thickness tears,” said Dr. Desmond John Bokor, lead study investigator and associate professor in the Department of Orthopaedic Surgery at Macquarie University in Australia. “The results of this study demonstrate the ability of the bioinductive implant to induce new tendon-like tissue, enabling partial-thickness rotator cuff tears to decrease in size and in most cases disappear. The ability to heal partial-thickness rotator cuff defects, and thus prevent tear propagation and progressive tendon degeneration, represents a novel interventional treatment paradigm for these lesions.”
Company comments
“This study is further evidence that the Rotation Medical rotator cuff system has the potential to transform the treatment of rotator cuff disease,” said Martha Shadan, president and CEO of Rotation Medical. “Our bioinductive implant addresses both the biomechanics and biology required to heal a rotator cuff tendon tear, preventing rotator cuff tears from becoming larger over time, reducing the incidence of re-tears and, in some cases, shortening patient recovery time.”
Source: Rotation Medical, Inc.
published: September 8, 2016 in: Clinical Studies/Trials, News, Shoulder