RecruitingNCT06788717

MDR - Comprehensive Primary Revision Stems PMCF

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study


Sponsor

Zimmer Biomet

Enrollment

59 participants

Start Date

Jun 19, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Comprehensive Primary Revision Stems for people with shoulder arthritis, shoulder disease, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEComprehensive Primary Revision Stems

Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.


Locations(2)

Cedars Sinai Medical Center

Los Angeles, California, United States

Aalborg University Hospital

Aalborg, Denmark

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NCT06788717


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