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MDR ExploR Radial Head System PMCF
Sponsor: Zimmer Biomet
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.
Official title: Post-market Clinical Follow-up Study of the ExploR™ Radial Head System (Implants and Instrumentation) - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
93
Start Date
2022-08-16
Completion Date
2035-07-19
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
ExploR Radial Head
Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.
Locations (2)
Norton Healthcare
Louisville, Kentucky, United States
Akershus University Hospital
Lørenskog, Norway