A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
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 November 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 http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157 and http://www.depuy.com/countries_list.
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis.
Device: DePuy ASR™ Hip System
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Single-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy ASR™ Hip in Subjects With Suitable Indications for a Primary Resurfacing Hip Arthroplasty|
- Kaplan-Meier survivorship at two years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- UCLA Activity Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
- WOMAC Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Activity Assessment. [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Kaplan-Meier survivorship calculation [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
- Harris Hip Score [ Time Frame: pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
- Metal ion analysis in whole blood [ Time Frame: 3mths, 6mths, 1yr, 2yrs and 5 yrs post-surgery ] [ Designated as safety issue: No ]
- Bone mineral density (DEXA) [ Time Frame: 3mths, 1yr, 2yrs and 5 yrs post-surgery ] [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
Device: DePuy ASR™ Hip System
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872794
|St Augustine's Hospital|
|Durban, South Africa|