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.

Study Type: Observational

Study Design: Other, Prospective

Study Primary Completion Date: June 2016

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 Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Ken Beres, MD Principal Investigator Biomet Orthopedics, LLC  

Overall Contact: Erica Hoenie 574-371-1088 erica.hoenie@biomet.com

Information obtained from ClinicalTrials.gov on July 02, 2009

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