Outcomes Study of Rotator Cuff Repair Using the REGENETEN Bioinductive Implant A Prospective Multi-Center Global Registry

What this Trial Is About

Researchers are collecting real-world data on patients undergoing rotator cuff repair using the REGENETEN Bioinductive Implant System. This prospective, single-arm, multicenter registry involves up to 50 centers across the United Kingdom, Europe, and Australia, aiming to enroll up to 400 patients. The study focuses on evaluating clinical and health economic outcomes after surgery for rotator cuff injuries. Participants receive arthroscopic rotator cuff repair surgery augmented with the REGENETEN Bioinductive Implant, a device designed to manage and protect tendon injuries without substantial tendon tissue loss. Patients are treated according to standard medical care, and the study gathers data on their recovery and outcomes over time. Participants will be monitored up to two years after surgery with regular assessments including quality of life, arm and shoulder function, pain levels, and shoulder-specific scores at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. Additional data on retear rates, postoperative recovery, sling use, mobilization time, and return to work are also collected. The study provides long-term insight into patient progress following the use of the implant.

Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant