ExploR™ Modular Radial Head Data Collection
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||ExploR™ Modular Radial Head Data Collection|
- We will measure the performance and clinical outcomes of the ExploR Modular Radial Head based on data collection from the following forms: The Mayo Clinic Performance Index for The Elbow, The Quick DASH Outcome Measure, Radiographic Evaluation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Patient examination measurements and radiographic measurements will be used to determine the effects of the Modular Radial Head implant. [ Time Frame: Pre-op, 6 week, 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, 5 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||August 2020|
|Estimated Primary Completion Date:||August 2020 (Final data collection date for primary outcome measure)|
Patient will receive modular radial head replacement. This is only a data collection study so this replacement is standard of care.
Device: Explore Modular Radial Head
Patient will receive a modular radial head replacement.
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.
The radial head on which data will be collected is legally marketed and is not investigational or experimental. This data collection effort will document the clinical outcomes of the radial head.
Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational surgical techniques used. The devices and products are to be used in accordance with their instructions for use and/or approved labeling.
The outcomes and data collected include:
The Mayo Clinic Performance Index for The Elbow The Quick DASH Outcome Measure Radiographic Evaluation
All revisions, complications, and adverse events will also be recorded. 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
Patient selection factors to be considered:
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions, including control of weight and activity levels
- A good nutritional state of the patient
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521846
|Contact: Julie M Daniels, BBA||6153224506||Julie.M.Daniels@vanderbilt.edu|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232-8828|
|Contact: Julie M Daniels, BBA 615-322-4506 Julie.M.Daniels@vanderbilt.edu|
|Principal Investigator:||Donald H Lee, MD||Vanderbilt University|