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A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery

NCT00208377 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2017-06-26

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

DePuy ASR Hip System

A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty

Sponsors & Collaborators

  • DePuy International

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Australia
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00208377 on ClinicalTrials.gov