Rotation Medical today released results from a study of its Bioinductive Implant designed for repairing rotator cuff tears, touting the device’s ability to consistently heal such tears and mitigate tear progression.
Results from the 33-patient study were published in the Journal of Shoulder and Elbow Surgery, the Plymouth, Minn.-based company said.
In the trial, researchers investigated the use of the Bioinductive Implant in patients with chronic, degenerative, intermediate to high-grade partial-thickness tears.
Outcomes were assessed using the American Shoulder and Elbow Surgeons and Constant-Murley scores preoperatively and at 3 and 12 months post-procedure. Magnetic resonance imaging was also performed to assess tendon healing and thickness at the original tear site.
“Partial thickness rotator cuff tears do not heal spontaneously and have a high propensity to increase in size and/or develop into full-thickness lesions. This study shows that the Bioinductive Implant not only repairs the tear and increases tendon thickness, but it also prevents tear progression. In addition, because the native tendon footprint remains intact around the location of the defect, the Bioinductive Implant may accelerate rehabilitation and recovery as compared with more conservative postoperative management when partial thickness lesions are taken down and repaired as full thickness tears,” lead investigator Dr. Theodore Schlegel of the Steadman Hawkins Clinic Denver said in a prepared statement.
Results indicated significant improvement in clinical scores and an increase in mean tendon thickness of 2mm, with new tissue indistinguishable from the underlying tendon. A total 94% of patients experienced complete healing or considerable reductions in defect size.
Rotation Medical said that consistent partial to complete fill-in of the original bursal, intrasubstance and articular partial-thickness tear defects were observed as early as 3 months post-operation, with sustained efficacy through 12 months.
A total of 94% of patients agreed or strongly agreed they were satisfied with results of the surgery, and no tears progressed to full-thickness in patients who followed post-op rehabilitation plans. No serious adverse events were reported.
“In addition to further demonstrating that our Bioinductive Implant increases tendon thickness and prevents re-tears, we are pleased that the majority of patients in this study said they were satisfied with the results of their rotator cuff surgeries. As health systems transition to value-based care, data like these are becoming increasingly necessary to demonstrate the effectiveness of medical devices on indicators such as patient satisfaction, in addition to key health economic drivers that we are measuring in our REBUILD Registry Study,” prez & CEO Martha Shadan said in a press release.