Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208377
Status:
TERMINATED
Last Update Posted:
2017-06-26
First Post:
2005-09-13
Brief Title:
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR System in Primary Hip Resurfacing Surgery
Sponsor:
DePuy International
Organization:
DePuy International
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DePuy discontinued this product in 4Q2009 At the time of this decision DePuy reviewed all clinical studies for this product and decided to close this Study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 httpwwwmhragovukPublicationsSafetywarningsMedicalDeviceAlertsCON079157 and httpwwwdepuycomcountries_list
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 httpwwwmhragovukPublicationsSafetywarningsMedicalDeviceAlertsCON079157 and httpwwwdepuycomcountries_list
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None