TerminatedNot Applicable

ExploR® Modular Radial Head Data Collection

Stopped: There was a lack of business need to continue this data collection.

United States4 participantsStarted 2009-12

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. This data collection effort will document the clinical outcomes of the radial head.

Who can participate

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

✓. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
✓. 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

Exclusion criteria

✕. Infection
✕. Sepsis
✕. Osteomyelitis
✕. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
✕. Osteoporosis
✕. Metabolic disorders which may impair bone function
✕. Osteomalacia
✕. Distant foci of infections which may spread to the implant site

What they're measuring

Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation

Timeframe: 5 years

Trial details

NCT IDNCT00533234

SponsorBiomet Orthopedics, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

View on ClinicalTrials.gov More Degenerative Conditions of the Radial Head/Neck trials