Clinical Trial: A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Prospective Multi-Centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-Term Performance of the DePuy ASR Hip System in Subjects With Suitable Indications for a Primary Resurfaci

Brief Summary:

The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined and undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored.

DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from December 2010 to allow for the completion of the 5 year follow up assessments.

Please note that subsequent to this decision DePuy voluntarily recalled the ASR products on 24 August 2010. Additional information regarding this voluntary recall and the follow-up of patients affected by the recall can be found at the following links and

Detailed Summary:
Sponsor: DePuy International

Current Primary Outcome: Kaplan-Meier survivorship calculated annually [ Time Frame: Annually ]

Original Primary Outcome:

Current Secondary Outcome:

  • UCLA Activity Score [ Time Frame: 3 months, 6 months and then annually ]
  • WOMAC Score [ Time Frame: 3 months, 6 months and then annually ]
  • Activity Assessment [ Time Frame: 3 months, 6 months and then annually ]
  • Harris Hip Score [ Time Frame: 3mths, 1yr, 2 yrs, 5yrs, 10yrs and 15yrs post-surgery ]
  • Radiographic analysis [ Time Frame: pre-discharge, 3mths, 1yr, 2 yrs, 5yrs, 10yrs and 15yrs post-surgery ]
  • Metal ion analysis in whole blood [ Time Frame: 3mths, 1yr, 2yrs and 5yrs post surgery ]
  • Bone mineral density (DEXA) [ Time Frame: pre-discharge, 3mths, 1yr, 2yrs and 5yrs post-surgery ]

Original Secondary Outcome:

Information By: DePuy International

Date Received: September 13, 2005
Date Started: July 2003
Date Completion:
Last Updated: August 3, 2016
Last Verified: July 2016