The purpose of this study is to monitor the performance of a large metal-on-metal bearing from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery or a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. The Study was terminated with effect from 30th November 2011 following the completion of 2 year follow up assessments for those patients remaining in the study. Please note that prior 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/CON155761 and http://www.depuy.com/countries\_list.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
329
Resurfacing system
Large Metal-on-Metal Total Hip Replacement
University Clinic for Orthopaedics and Orthopaedic Surgery - LKH
Graz, Austria
Znojmo Hospital
Znojmo, Czechia
Coxa, Hospital for Joint Replacement
Tampere, Finland
Klinikum der Universität zu
Cologne, Germany
Elverum Hospital
Elverum, Norway
Hospital Curry Cabral
Lisbon, Curry Cabral, Portugal
Kant. Spital Sursee-Wolhusen
Wolhusen, Switzerland
Royal Berkshire Hospital, UK
Reading, Berkshire, United Kingdom
Kaplan-Meier survivorship calculated at the five-year time-point
Time frame: 5yrs
Annual Kaplan-Meier survivorship calculations
Time frame: Annually
Harris Hip Score
Time frame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
Radiographic analysis
Time frame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
Oxford Hip Score
Time frame: 3mths, 6mths and annually post-surgery
UCLA Activity Score
Time frame: 3mths, 6mths and annually post-surgery
Hip Outcome Score
Time frame: 3mths, 6mths and annually post-surgery
EuroQol EQ-5D
Time frame: 3mths, 6mths and annually post-surgery
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