Long-term Safety and Performance Study of Zimmer Biomet Total Shoulder Arthroplasty Systems

What this Trial Is About

This research aims to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems used in primary anatomic shoulder arthroplasty. It is a multicenter, prospective, non-controlled post market surveillance study focusing on patients with shoulder conditions such as osteoarthritis, fractures, rheumatoid arthritis, and other degenerative joint diseases. The study evaluates safety by monitoring adverse events and measures clinical benefits including pain, function, quality of life, and radiographic parameters. Participants will receive the Zimmer Biomet Total Shoulder Arthroplasty System, including the Alliance Glenoid implant, as part of their primary total shoulder arthroplasty procedure. The study does not include a control group and involves long-term follow-up to assess the devices performance and safety. The primary endpoint is improvement in the American Shoulder and Elbow Surgeons ASES shoulder score at 2 years, with secondary endpoints including adverse event frequency, quality of life assessments EQ-5D-5L, and radiographic performance over 10 years. During the study, participants will be monitored for clinical outcomes such as pain relief, shoulder function, and quality of life through standardized assessments and imaging studies. Follow-up visits will continue up to 10 years to track safety and device performance. Researchers will collect data on adverse events and changes in radiographic parameters to evaluate long-term effects. Participants are expected to complete all required follow-up assessments and provide informed consent before joining.

Zimmer Biomet Shoulder Arthroplasty PMCF Study