Official Title: “A Prospective Clinical Study On A Total Hip Resurfacing System”

This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Study Type: Interventional

Study Design: Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2012

Intervention(s) in this Clinical Trial

• Device: ReCap Total Hip Resurfacing System
  • This is a hip resurfacing system.

Arms, Groups and Cohorts in this Clinical Trial

• Other: ReCap
  • ReCap Total Hip Resurfacing System

Primary Measures

• Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
  • Time Frame: 2 years postoperative
    Safety Issue?: Yes

Secondary Measures

• Complications
  • Time Frame: Anytime
    Safety Issue?: Yes

Inclusion Criteria:

• intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:
• Osteoarthritis
• Avascular necrosis
• Traumatic arthritis
• Legg Perthes
• Rheumatoid arthritis

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, Inc.

Overall Clinical Trial Officials and Contacts

H P Delport, MD Principal Investigator AZ NIKOLAAS CAMPUS SINT NIKLAAS  

Overall Contact: Fabienne Lambert 32-3 870 65 77 fabienne.lambert@biometeurope.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00604734

Study ID Number: EU-8

ClinicalTrials.gov Identifier: NCT00604734

Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment