ExploR® Modular Radial Head Data Collection
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|ClinicalTrials.gov Identifier: NCT00533234|
Recruitment Status : Terminated (There was a lack of business need to continue this data collection.)
First Posted : September 21, 2007
Last Update Posted : June 21, 2017
|Condition or disease||Intervention/treatment|
|Degenerative Conditions of the Radial Head/Neck Post-traumatic Conditions of the Radial Head/Neck||Device: ExploR® Modular 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|
|Actual Enrollment :||4 participants|
|Official Title:||ExploR® Modular Radial Head Data Collection|
|Study Start Date :||December 2009|
|Actual Study Completion Date :||June 2010|
- Device: ExploR® Modular Radial Head
The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533234
|United States, Indiana|
|Biomet Orthopedics, LLC|
|Warsaw, Indiana, United States, 46581|
|Principal Investigator:||Ken Beres, MD||Biomet Orthopedics, LLC|