Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208455
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 PROXIMA Hip in Primary Total Hip Replacement
Sponsor:
DePuy International
Organization:
DePuy International
Study Overview
Official Title:
An Uncontrolled Multi-Centre Prospective Post Marketing Surveillance Study to Monitor the Long Term Survivorship of the DePuy PROXIMA Hip in Subjects Requiring a Total Hip Replacement
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DePuy discontinued this product in 2013 the clinical program was reviewed and this Study was closed
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 of the DePuy PROXIMA hip in the treatment of patients with hip joint disease requiring 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 A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored
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