ExploR® Modular Radial Head Data Collection
Stopped early
Conditions studied: Degenerative Conditions of the Radial Head/Neck, Post-traumatic Conditions of the Radial Head/Neck
In brief
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.
Key facts
- Study ID
- NCT00533234
- Run by
- Biomet Orthopedics, LLC
- People needed
- 4
- Starts
- 2009-12-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2017-06-21
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The inclusion criteria will be the same as the indications stated in the FDA cleared (510(k) K040611) and (510(k) K051385) labeling for the device.
- 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
- The device is intended for single use with or without bone cement.
- Modular Radial Head replacement prostheses have received FDA clearance for cemented and non-cemented application.
- Patient selection factors to be considered include: 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, and 4) the patient must have reached full skeletal maturity.
You may not qualify if…
- The exclusion criteria will be the same as the contraindications stated in the FDA cleared labeling (510(k) K040611) and (510(k) K051385) for the device. These contraindications include:
- Absolute contraindications:
- Infection
- Sepsis
- Osteomyelitis
- Relative contraindications:
- 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
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Where it is running
- Biomet Orthopedics, LLC — Warsaw, Indiana, United States
Full record on ClinicalTrials.gov
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