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Recruiting NCT06788717

MDR - Comprehensive Primary Revision Stems PMCF

Trial Parameters

Condition Shoulder Pain
Sponsor Zimmer Biomet
Study Type OBSERVATIONAL
Phase N/A
Enrollment 59
Sex ALL
Min Age 18 Years
Max Age 100 Years
Start Date 2025-06-19
Completion 2035-07
Interventions
Comprehensive Primary Revision Stems

Brief Summary

The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.

Eligibility Criteria

Inclusion Criteria * Patient must be 18 years of age or older. * Patient must be willing and able to follow directions. * Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem Exclusion Criteria * Off-label use. * Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent. * Patient is unwilling to sign informed consent. * Uncooperative patient or patient with neurologic disorders who are incapable of following directions.

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