Degenerative Conditions of the Radial Head/Neck, Post-traumatic Conditions of the Radial Head/Neck
Conditions
Keywords
Elbow fracture, Elbow dislocation, Radial head fracture, Radial neck fracture
Brief 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.
Detailed description
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.
Interventions
DEVICEExploR® Modular Radial Head
The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.
Sponsors
Biomet Orthopedics, LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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. 1. 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 2. Primary replacement after fracture of the radial head 3. Symptomatic sequelae after radial head resection 4. 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.
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Revisions, Complications, Adverse Events | 5 years |
Countries
United States
Outcome results
None listed