MDR ExploR Radial Head System PMCF
NCT05583448 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 93
Last updated 2026-02-04
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.
Conditions
- Elbow Injury
Interventions
- DEVICE
-
ExploR Radial Head
Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.
Sponsors & Collaborators
-
Zimmer Biomet
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-16
- Primary Completion
- 2026-08-16
- Completion
- 2035-07-19
- FDA Device
- Yes
Countries
- United States
- Norway
Study Locations
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