Clinical trial NCT00521846: ExploR™ Modular Radial Head Data Collection
Official title: ExploR™ Modular Radial Head Data Collection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Elbow Fracture
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2007-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be any individual that seeks care at Vanderbilt University Medical Center for a radial head fracture/dislocation that requires replacement using a Biomet Explor Modular Radial Head implant (routine care).

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 5 years
measure: Patient examination measurements and radiographic measurements will be used to determine the effects of the Modular Radial Head implant.
timeFrame: Pre-op, 6 week, 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Donald H Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: