A Prospective Clinical Study On A Total Hip Resurfacing System

Verified by: Biomet, Inc., June 2011
First Received: December 23, 2007 | Last Updated: June 7, 2011 | Phase: N/A | Start Date: September 2004
Overall Status: Active, not recruiting | Estimated Enrollment: 300
  • …
  • Tell a FriendPrint

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

Brief Summary

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: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Biomet, Inc. Industry

Overall Clinical Trial Officials and Contacts

H J Hoekstra, MD Principal Investigator St. Anna hospital, Geldrop  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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)

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00603395