Lorsch

Researchers are studying patients with rotator cuff injuries who are undergoing arthroscopic rotator cuff repair surgery. This study collects real-world data on the outcomes of using the REGENETEN Bioinductive Implant System, a medical device designed to manage and protect rotator cuff tendon injuries where there has been no significant loss of tendon tissue. The registry involves multiple centers across the United Kingdom, Europe, and Australia and plans to enroll up to 400 patients. Participants will receive arthroscopic rotator cuff repair surgery augmented with the REGENETEN Bioinductive Implant as part of their standard medical care. The implant is intended to support tendon healing in either partial or full thickness tendon tears. This is a prospective, single-arm study without a comparison group, focusing on collecting data after surgery. Patients will be followed and evaluated at multiple time points up to two years after surgery. Assessments include quality of life, arm and shoulder function, shoulder pain levels, and overall shoulder evaluation using several validated scoring systems. Data will be collected at baseline before surgery and at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery to monitor recovery and outcomes over time.