Evaluation of Healing Rates and Safety With a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes

Background: Failure of repair of large and massive rotator cuff tears is a challenging problem within orthopaedics. Poor tendon tissue and vascularity are known causes for failure of rotator cuff repairs. Purpose: To assess the safety, outcomes, and healing rates when large and massive rotator cuff repairs are augmented with a bioinductive collagen scaffold patch in a proof-of-principle design. Study Design: Case series; Level of evidence, 4. Methods: Twenty-three patients undergoing repair of full-thickness large (2-tendon) or massive (3-tendon) rotator cuff tears augmented with a bioinductive collagen patch were enrolled in a prospective single-arm proof-of-principle study. No partial repairs were performed, and a complete rotator cuff repair was successfully achieved in each case. Sixteen patients underwent revision rotator cuff repairs versus 7 primary repairs. Safety was determined by any implant-related adverse event. A single magnetic resonance imaging (MRI) scan was utilized to confirm tendon healing and thickness at a minimum of 6 months postoperatively. Postoperative ultrasound (US) was used in office by the treating surgeon to assess tendon thickness at 3-, 6-, 12-, and 24-month intervals. American Shoulder and Elbow Surgeons (ASES) scores were collected at final follow-up. Results: Overall, a 96% (22 of 23) healing rate was confirmed on US and MRI. However, incidence of treatment clinical failure was 9% (2 of 23), as 1 patient's tendon healed but eventually underwent additional surgery. There were no adverse events attributed to the implant reported. Final US rotator cuff thickness was 7.28 +/- 0.85 mm (mean +/- SD), and final MRI rotator cuff thickness was 5.13 +/- 1.06 mm. The mean ASES score at final follow-up was 82.87 +/- 16.68 (range, 53.33-100). Conclusion: No complications attributed to the implant were reported, and new tendon formation was apparent on US and MRI, with relatively high healing rates at 2-year follow-up. Arthroscopic application of this bioinductive collagen scaffold when combined with rotator cuff repair is a safe and effective treatment for healing of large and massive rotator cuff repairs.