ExploR™ Modular Radial Head Data Collection



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 2007
End Date:August 2020
Contact:Julie M Daniels, BBA
Email:Julie.M.Daniels@vanderbilt.edu
Phone:6153224506

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The purpose of this prospective clinical data collection is to document the performance and
clinical outcomes of the ExploR Modular Radial Head.

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

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
We found this trial at
1
site
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Phone: 615-322-4506
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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