Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208325
Status:
TERMINATED
Last Update Posted:
2016-09-13
First Post:
2005-09-13
Brief Title:
PFC Sigma Fixed and Mobile Knee Study
Sponsor:
DePuy International
Organization:
DePuy International
Study Overview
Official Title:
Clinical Evaluation of the PFC Sigma Fixed Bearing and PFC Sigma RP Mobile Bearing Total Knee Systems
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated at the point the primary endpoint and early milestones were reached and because long term outcomes were available from other sources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this investigation is to evaluate the performance in terms of post-operative active range of motion at one year of the PFC Sigma and PFC Sigma Rotating Platform total knee systems in clinical practice
Detailed Description:
The secondary objectives of this investigation areTo evaluate the performance of the PFC Sigma and PFC Sigma Rotating Platform total knee systems in clinical practice To evaluate the impact of patellar resurfacing on the performance of the PFC Sigma and the PFC Sigma Rotating Platform total knee systems To evaluate the impact of Posterior Cruciate Ligament PCL sacrifice or retention on the performance of the PFC Sigma and the PFC Sigma Rotating Platform total knee systems
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