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: September 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 J Hoekstra, MD Principal Investigator St. Anna hospital, Geldrop  

Overall Contact: Walter van der Weegen 06-34282788 w.vander.weegen@st-anna.nl

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00603395

Study ID Number: EU-6

ClinicalTrials.gov Identifier: NCT00603395

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)