ExploR® Modular Radial Head Data Collection

Official Title: “ExploR® Modular Radial Head Data Collection”

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.

Data collection intervals are:

Pre-operative, Operative, 3 Months Post-op, 1 Year Post-op, 3 Years Post-op, and 5 Years Post-op.

Data collected includes:

Historical data, Operative record, Mayo Clinic Performance Index for the Elbow, Quick DASH Outcome Measure, Complications, Lost to Follow-up, Protocol Deviations, and Radiographic evaluation of elbow and wrist.

Intervention(s) in this Clinical Trial

• Device: ExploR® Modular Radial Head
  • The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.

Primary Measures

• Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation
  • Time Frame: 5 years
    Safety Issue?: No

Secondary Measures

• Revisions, Complications, Adverse Events
  • Time Frame: 5 years
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Biomet Orthopedics, LLC Industry

Overall Clinical Trial Officials and Contacts

Ken Beres, MD Principal Investigator Biomet Orthopedics, LLC  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00533234

Study ID Number: 116-U-001

ClinicalTrials.gov Identifier: NCT00533234

Health Authority: United States: Institutional Review Board