MDR ExploR Radial Head System PMCF
Part of paid clinical trials in Louisville, Kentucky.
- Sponsor
- Zimmer Biomet
- Study ID
- NCT05583448
- Status
- Enrolling By Invitation
Conditions
- Elbow Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ExploR Radial Head — DEVICEPatient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.
Study Details
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.
Key Dates
- Start date
- Aug 16, 2022
- Status verified
- Feb 2026
- Primary completion
- Aug 16, 2026
- Completion
- Jul 19, 2035
Study Design
- Enrollment
- 93 participants (estimated)
Arms
- Arm: ExploR Radial HeadSubjects who have received the ExploR Radial Head Device.
Primary Outcome Measure
Device Survivorship [ Time Frame: 10 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Norton Healthcare | Louisville | Kentucky | 40241 | - |
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