Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT00289094
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2006-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
Sponsor:
DePuy Orthopaedics
Organization:
Study Overview
Official Title:
Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
Detailed Description:
This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: