Rheumatoid Arthritis Clinical Trial
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 Resurfacing Hip Arthroplasty
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.
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