New elbow implant shows promise in small study
NCT ID NCT00521846
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tracked 61 patients who received the ExploR Modular Radial Head implant to repair elbow fractures. Researchers measured pain, motion, and function using standard elbow scores and X-rays. The goal was to see how well the implant performs in everyday use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Biomet ExploR Modular Radial Head implant
- What this could lead to
- If successful, this implant could provide a reliable option for restoring elbow function after severe fractures.
- What could go wrong
- This is a small, completed data collection study with no control group, so results may not apply to all patients. Implant risks include infection, loosening, or need for revision surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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61 people
The number who actually took part.
- Started
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Aug 2007
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Study population will be any individual that seeks care at Vanderbilt University Medical Center for a radial head fracture/dislocation that requires replacement using a Biomet Explor Modular Radial Head implant (routine care).
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 1. Joint destruction and/or subluxation visible on x-ray 2. Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty Patient selection factors to be considered: 1. Need to obtain pain relief and improve function 2. Ability and willingness of the patient to follow instructions, including control of weight and activity levels 3. A good nutritional state of the patient 4. The patient must have reached full skeletal maturity Exclusion Criteria Patients who have infection, sepsis, and osteomyelitis Patients who are uncooperative or have neurologic disorders who is capable or unwilling to follow directions Patients with distant foci of infections which may spread to the implant site Patients with rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Patients who are pregnant Patients who are under 18 years of age Patients who have had fractures of the humerus Patients who have had revisions where other devices and treatments have failed
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Vanderbilt University
Nashville, Tennessee, 37232-8828, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.