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| Sponsor: | Biomet Orthopedics, LLC |
|---|---|
| Information provided by: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT00533234 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Degenerative Conditions of the Radial Head/Neck Post-traumatic Conditions of the Radial Head/Neck |
Device: ExploR® Modular Radial Head |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | ExploR® Modular Radial Head Data Collection |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The study population will be implanted with the ExploR® Modular Radial Head.
Inclusion Criteria:
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:
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.
Exclusion Criteria:
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:
Relative contraindications:
Contacts and Locations| Contact: Erica Hoenie | 574-371-1088 | erica.hoenie@biomet.com |
| United States, Indiana | |
| Biomet Orthopedics, LLC | Recruiting |
| Warsaw, Indiana, United States, 46581 | |
| Contact: Erica Hoenie, B.S. 800-348-9500 ext 1088 erica.hoenie@biomet.com | |
| Principal Investigator: | Ken Beres, MD | Biomet Orthopedics, LLC |
More Information
| Responsible Party: | Biomet Orthopedics, LLC ( Ken Beres, MD ) |
| Study ID Numbers: | 116-U-001 |
| Study First Received: | September 20, 2007 |
| Last Updated: | December 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00533234 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Elbow fracture Elbow dislocation Radial head fracture Radial neck fracture |