Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208364
Status:
TERMINATED
Last Update Posted:
2016-10-07
First Post:
2005-09-13
Brief Title:
A Two Centre Study to Assess the Long-term Performance of the Pinnacle Cup With a Metal-on-Metal Bearing in Primary Total Hip Replacement
Sponsor:
DePuy International
Organization:
DePuy International
Study Overview
Official Title:
Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup Prosthesis With a Metal on Metal Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated early due to business reasons
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 Pinnacle Cup with a metal-on-metal bearing combination 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 also have blood samples taken at regular intervals to allow the metal ion levels to be determined
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