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Clinical Trial Summary

The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation) when used for radial head arthroplasty.


Clinical Trial Description

This is a global, multi-center, retrospective enrollment, prospective follow-up, consecutive series post-market clinical follow-up study. The intent of the study is that subjects who have already had the surgical implant will be retrospectively enrolled in the study and data will be collected for a minimum of 10 years post-operatively. Subjects treated with the device will be identified and invited to participate in the study. 93 subjects will be enrolled into the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05583448
Study type Observational
Source Zimmer Biomet
Contact
Status Enrolling by invitation
Phase
Start date August 16, 2022
Completion date July 19, 2035

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