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 http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157 and http://www.depuy.com/countries\_list.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
228
A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty
Sportsmed SA
Stepney, Australia
Bundesknappshaft Klinik
Püttlingen, Germany
Epsom General Hospital
Surrey, United Kingdom
Kaplan-Meier survivorship calculated annually
Time frame: Annually
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
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