NCT06920459 Zimmer Biomet Shoulder Arthroplasty PMCF Study

Trial Parameters

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * Patient must be 20 years of age or older. * Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants. * Patient is a candidate for shoulder arthroplasty due to one or more of the following: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. Rheumatoid arthritis. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. Difficult clinical management problems, where other method of treatment may not be suitable or may be inadequate. * Patient must be able and willing to complete the protocol required follow-up. * Patient must be able and willing to sign the IRB/EC approved informed consent. Exclusion Criteria: * Patient is unwilling or unable to give consent or to comply with the follow-up program. * Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study. * Patient is known t

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