Trials / Terminated
TerminatedNCT00533234
ExploR® Modular Radial Head Data Collection
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 4 (actual)
- Sponsor
- Biomet Orthopedics, LLC · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR® Modular Radial Head. This data collection effort will document the clinical outcomes of the radial head.
Detailed description
Data collection intervals are: Pre-operative, Operative, 3 Months Post-op, 1 Year Post-op, 3 Years Post-op, and 5 Years Post-op. Data collected includes: Historical data, Operative record, Mayo Clinic Performance Index for the Elbow, Quick DASH Outcome Measure, Complications, Lost to Follow-up, Protocol Deviations, and Radiographic evaluation of elbow and wrist.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ExploR® Modular Radial Head | The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement. |
Timeline
- Start date
- 2009-12-01
- Completion
- 2010-06-01
- First posted
- 2007-09-21
- Last updated
- 2017-06-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00533234. Inclusion in this directory is not an endorsement.