ExploR® Modular Radial Head Data Collection
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Degenerative Conditions of the Radial Head/Neck; Post-Traumatic Conditions of the Radial Head/Neck
Intervention: ExploR® Modular Radial Head (Device)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Biomet Orthopedics, LLC Official(s) and/or principal investigator(s):
Ken Beres, MD, Principal Investigator, Affiliation: Biomet Orthopedics, LLC
Overall contact:
Erica Hoenie, Phone: 574-371-1088, Email: erica.hoenie@biomet.com
Summary
The purpose of this prospective clinical data collection is to document the performance and
clinical outcomes of the ExploR® Modular Radial Head. This data collection effort will
document the clinical outcomes of the radial head.
Clinical Details
Official title: ExploR® Modular Radial Head Data Collection
Study design: Other, Prospective
Primary outcome: Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation
Secondary outcome: Revisions, Complications, Adverse Events
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
The inclusion criteria will be the same as the indications stated in the FDA cleared
(510(k) K040611) and (510(k) K051385) labeling for the device.
1. 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
2. Primary replacement after fracture of the radial head
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty
The device is intended for single use with or without bone cement.
Modular Radial Head replacement prostheses have received FDA clearance for cemented and
non-cemented application.
Patient selection factors to be considered include: 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, and 4) the patient must have reached full skeletal maturity.
Exclusion Criteria:
The exclusion criteria will be the same as the contraindications stated in the FDA cleared
labeling (510(k) K040611) and (510(k) K051385) for the device. These contraindications
include:
Absolute contraindications:
1. Infection
2. Sepsis
3. Osteomyelitis
Relative contraindications:
1. Uncooperative patient or patient with neurologic disorders who is incapable or
unwilling to follow directions
2. Osteoporosis
3. Metabolic disorders which may impair bone function
4. Osteomalacia
5. Distant foci of infections which may spread to the implant site
6. Rapid joint destruction, marked bone loss or bone resorption apparent on
roentgenogram.
Locations and Contacts
Erica Hoenie, Phone: 574-371-1088, Email: erica.hoenie@biomet.com
Biomet Orthopedics, LLC, Warsaw, Indiana 46581, United States
Additional Information
Starting date: July 2009
Ending date: June 2016
Last updated: June 26, 2009
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