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...

Date First Received: September 20, 2007

Last Updated: July 3, 2008

Verified by: Biomet, Inc., July 2008

Clinical Trial Phase: N/A | Start Date: November 2007

Overall Status: Recruiting

Estimated Enrollment: 20

Brief Summary

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

Intervention(s) in this Clinical Trial

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Need to obtain pain relief and improve function
  • Ability and willingness of the patient to follow instructions, including control of weight and activity levels
  • A good nutritional state of the patient
  • The patient must have reached skeletal maturity

Exclusion Criteria:

  • Infection
  • Sepsis
  • Osteomyelitis
  • Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
  • Osteoporosis
  • Metabolic disorders which may spread to the implant site
  • Osteomalacia
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent or 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

Clinical Trial Sponsor Information

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Ken Beres, MD Principal Investigator Biomet Orthopedics, LLC  

Overall Contact: Erica Hoenie 574-267-6639 erica.hoenie@biomet.com

Additional Information

Information obtained from ClinicalTrials.gov on August 28, 2008

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

Clinical Trials Authorship and Review

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