Elbow Fracture
Conditions
Brief summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.
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
Interventions
DEVICEBiomet Explor Modular Radial Head Replacement
As part of the patient's routine care, they will undergo a radial head replacement using the Biomet Explor Modular Radial Head system.
Sponsors
Vanderbilt University Medical Center
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 5 years |
| Patient examination measurements and radiographic measurements will be used to determine the effects of the Modular Radial Head implant. | Pre-op, 6 week, 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, 5 year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDonald H Lee, MD
Vanderbilt University Medical Center
Outcome results
None listed