Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry.

PURPOSE

The purpose of this study was to prospectively collect safety and efficacy data in a large group of patients undergoing arthroscopic repair of full-thickness rotator cuff tears augmented with a resorbable bioinductive bovine collagen implant designed to promote healing.

METHODS

Seventeen centers across the United States enrolled patients in an institutional review board-approved registry to collect outcomes data on the implant. Patients undergoing surgical management of full-thickness rotator cuff tears augmented with the implant were enrolled. Inclusion criteria were age of ≥21 years, willingness to participate and the ability to read and speak English. Exclusion criteria included hypersensitivity to bovine-derived products. Patients were assessed before and after surgery at up to 1 year with outcomes including the single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12) mental components and physical components (VR-12 PCS), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcome measures. Ad hoc analyses were performed to compare these outcomes at all time points depending on tear size (small/medium vs large/massive). Serious complications were collected.

RESULTS

Of 210 patients enrolled, 192 had 1-year follow-up data available. The patients experienced statistically significant improvement between baseline and 1 year for mean SANE, VR-12 PCS, ASES, and WORC scores (40.0-82.0, 33.5-47.3, 46.2-87.8, and 36.2-81.0, respectively;  < .001 for all results). Ad-hoc analysis demonstrated that similar results were obtained at 1 year regardless of tear size. Twenty patients (10.4%) experienced serious complications (10.4%), including revision surgery (n = 18), proximal humerus fracture/partial subscapularis tear resulting from multiple falls (n = 1), and adhesive capsulitis (n = 1).

CONCLUSIONS

The safety and efficacy of a bioinductive implant in the surgical management of full-thickness rotator cuff tears at 1 year was shown in this study. Implant efficacy appears to be comparable regardless of the underlying tear size.

LEVEL OF EVIDENCE

Level IV, therapeutic case series.