Active — Not RecruitingNot Applicable

ExploR™ Modular Radial Head Data Collection

United States50 participantsStarted 2007-08

Plain-language summary

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Joint destruction and/or subluxation visible on x-ray
✓. Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty
✓. Need to obtain pain relief and improve function
✓. Ability and willingness of the patient to follow instructions, including control of weight and activity levels
✓. A good nutritional state of the patient
✓. The patient must have reached full skeletal maturity

What they're measuring

We will measure the performance and clinical outcomes of the ExploR Modular Radial Head based on data collection from the following forms: The Mayo Clinic Performance Index for The Elbow, The Quick DASH Outcome Measure, Radiographic Evaluation

Timeframe: 5 years

Patient examination measurements and radiographic measurements will be used to determine the effects of the Modular Radial Head implant.

Timeframe: Pre-op, 6 week, 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, 5 year

Trial details

NCT IDNCT00521846

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08

View on ClinicalTrials.gov More Elbow Fracture trials