Rotation Medical Inc announces the results of a study, published online in the Journal of Shoulder and Elbow Surgery, suggesting that its Bioinductive Implant consistently heals rotator cuff tears and mitigates tear progression.
“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,” says Theodore F. Schlegel, MD, lead investigator of the study and orthopedic surgeon at Steadman Hawkins Clinic Denver, in a media release from Rotation Medical.
“This study shows that the Bioinductive Implant not only repairs the tear and increases tendon thickness, but it also prevents tear progression.”
Schlegel adds that the Bioinductive Implant may also accelerate rehabilitation and recovery compared with more conservative postoperative management.
The study enrolled 33 patients with chronic, degenerative, intermediate- (n=12) to high-grade (n=21) partial-thickness tears (11 articular, 10 bursal, four intra-substance, eight hybrid) of the supraspinatus tendon. Clinical outcomes were assessed using American Shoulder and Elbow Surgeons (ASES) and Constant-Murley scores preoperatively and at three and 12 months postoperatively. Magnetic resonance imaging (MRI) was performed to assess postoperative tendon healing and thickness at the original tear site.
According to the study’s 1-year results, clinical scores improved significantly (p<0.0001), and mean tendon thickness increased by 2.0 mm (p<0.0001); 94% of patients experienced complete healing or considerable reduction in defect size; and 94% of patients either agreed or strongly agreed that they were satisfied with the results of their surgery.
In addition, the release continues, no tears progressed to full-thickness in patients who followed the postoperative rehabilitation protocol, and no serious adverse events related to the implant 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,” states Martha Shadan, president and CEO of Rotation Medical, in the release.
[Source(s): Rotation Medical Inc, Business Wire]