Windsor

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.

Researchers are collecting real world data to examine the safety and performance of the Synergy Cervical Disc System in adults with degenerative cervical disc disease. This observational study includes both prospective and retrospective parts, enrolling patients who have had or will have the Synergy Disc implanted. The study aims to provide information about the devices effects in typical clinical use settings. Participants either have already received the Synergy Cervical Disc implant and are included in the retrospective arm, or they have decided to undergo implantation and join the prospective arm. The study includes patients with nerve root or spinal cord compression due to disc herniation or osteophyte formation, who have symptoms like arm or neck pain and have not improved after at least 6 weeks of conservative treatment. During the study, participants will be monitored through regular assessments including the Neck Disability Index and tracking of any device-related adverse events up to 12 months after implantation. Additional evaluations such as pain levels, patient satisfaction, neurological function, and specific clinical criteria will be collected before surgery and at multiple postoperative time points, including 6 weeks, 3 months, 6 months, 12 months, and annually. The total follow-up period can extend up to several years, providing a comprehensive view of patient outcomes and device performance.