Zimmer Biomet Shoulder Arthroplasty PMCF Study
NCT06920459 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40
Last updated 2025-12-08
Summary
This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.
Conditions
- Shoulder Fractures
- Shoulder Arthritis Osteoarthritis
- Shoulder Injury
- Shoulder Pain
- Degenerative Joint Disease
- Arthritis Shoulder
Interventions
- DEVICE
-
Alliance™ Glenoid
Total Shoulder Arthroplasty using the Alliance™ Glenoid implant
Sponsors & Collaborators
-
Zimmer Biomet
lead INDUSTRY
Principal Investigators
-
Emilie Rohmer · Zimmer Biomet
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-29
- Primary Completion
- 2028-12-31
- Completion
- 2036-12-31
Countries
- Germany
- Netherlands
Study Locations
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