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.
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.
Study Type
OBSERVATIONAL
Enrollment
4
The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.
Biomet Orthopedics, LLC
Warsaw, Indiana, United States
Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation
Time frame: 5 years
Revisions, Complications, Adverse Events
Time frame: 5 years
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