ExploR™ Modular Radial Head Data Collection
Purpose
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.
Condition
- Elbow Fracture
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 1 | As part of their routine care, patient's will receive Biomet modular radial head replacement. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Vanderbilt University Medical Center
Study Contact
Detailed Description
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: 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