Trials / Terminated
TerminatedNCT00208377
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
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
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 228 (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 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
| Type | Name | Description |
|---|---|---|
| DEVICE | DePuy ASR Hip System | A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty |
Timeline
- Start date
- 2003-07-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2005-09-21
- Last updated
- 2017-06-26
Locations
3 sites across 3 countries: Australia, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT00208377. Inclusion in this directory is not an endorsement.