NCT00872547

Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement

Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of a Large Metal-on-Metal (MoM) Bearing Comprising a DePuy ASR™ Cup in Conjunction With Either a DePuy ASR™ Hip Resurfacing Femoral Component or a DePuy ASR™ XL Head in Subjects With Indications Suitable for Either a Primary Resurfacing Arthroplasty or Primary Total Hip Arthroplasty

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rheumatoid Arthritis
• Osteoarthritis
• Post-traumatic Arthritis
• Collagen Disorders
• Avascular Necrosis
• Nonunion of Femoral Fractures
• Congenital Hip Dysplasia
• Slipped Capital Femoral Epiphysis

Interventions

Type	Name	Description
DEVICE	DePuy ASR™ Hip System	Resurfacing system
DEVICE	DePuy ASR™ XL Head / ASR™ Acetabular Cup System	Large Metal-on-Metal Total Hip Replacement

Timeline

• Start date: 2006-09-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-03-31
• Last updated: 2016-08-04

Locations

8 sites across 8 countries: Austria, Czechia, Finland, Germany, Norway, Portugal, Switzerland, United Kingdom