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MDR - Comprehensive Primary Revision Stems PMCF

RECRUITINGSponsored by Zimmer Biomet
Actively Recruiting
SponsorZimmer Biomet
Started2025-06-19
Est. completion2035-07
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06788717

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

Age: 18 Years – 100 YearsHealthy volunteers accepted
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.

Conditions6

ArthritisShoulder ArthritisShoulder DiseaseShoulder FracturesShoulder InjuriesShoulder Pain

Locations1 site

Cedars Sinai Medical Center
Los Angeles, California, 900033
Ali ZafarAli.Zafar-Khan@cskerlanjobe.org

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