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Zimmer Biomet Shoulder Arthroplasty PMCF Study
Sponsor: Zimmer Biomet
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.
Official title: Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2025-04-29
Completion Date
2036-12-31
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
Alliance™ Glenoid
Total Shoulder Arthroplasty using the Alliance™ Glenoid implant
Locations (2)
ARCUS Kliniken Pforzheim
Pforzheim, Germany
Meander Medisch Centrum
Amersfoort, TZ, Netherlands