Wright Medical Group, an orthopaedic medical device company, has reported that the results of a prospective, randomized controlled clinical study evaluating biologic augmentation of arthroscopic rotator cuff repairs with Graftjacket Matrix were presented by Alan Barber at the Arthroscopy Association of North America (AANA) annual meeting.
The Graftjacket Matrix is a processed three-dimensional human dermal tissue matrix that allows the body to rebuild areas of deficient tissue.
The study showed that rotator cuff repairs augmented with Wright’s Graftjacket Matrix were intact in 84% of the patients while only 46% of those in the control group were intact as measured by magnetic resonance imaging (MRI). In addition, the study showed that patients in the Graftjacket Matrix study group gained superior function compared to the control group.
Wright Medical said that the arthroscopic arm of the Level-1 rotator cuff study included 36 patients with arthroscopic rotator cuff repair including 20 patients in the Graftjacket Matrix study group and 16 in the control group.
MRI follow-up at a minimum of 12 months showed 84% of the repairs with Graftjacket Matrix were intact, while only 46% of those in the control group were intact. In addition, there was significant improvement in the American Shoulder & Elbow Surgeons (ASES) and Constant-Murley scores (p=0.02 and 0.03 respectively).
The treatment of large to massive rotator cuff tears remains a significant clinical challenge with re-tear rates reported as high as 90%. There are over 400,000 rotator cuff repairs performed annually in the US with an estimated 75,000 of these considered large to massive.
Wright Medical claimed that the Graftjacket Matrix is the only soft-tissue graft shown to reduce the re-tear rate and provide functional improvements post-operatively in a multi-center, prospective, randomized, controlled study. The benefits may lead to better clinical outcomes for patients as well as economic benefits for the health care system by reducing the need for costly revision surgeries.