Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380861
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2006-09-26
Brief Title:
Does Implant Design Improve Postoperative Flexion
Sponsor:
DePuy Orthopaedics
Organization:
DePuy Orthopaedics
Study Overview
Official Title:
Does Implant Design Improve Postoperative FlexionA Prospective Randomized Comparative Multi-center Study Comparing PFC Sigma RP Knee Versus PFC Sigma RP-F Implanted in Simultaneous Bilateral Subjects
Status:
COMPLETED
Status Verified Date:
2023-07
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:
This study will evaluate whether design features of one implant design allows more knee bend than the other Patients will have 1 design in the left knee and 1 design in their right knee Both knee surgeries will be on the same day
Detailed Description:
The primary objective of this study is to determine whether the passive non-weight-bearing flexion is superior with the posterior-stabilized PFC Sigma RP-F compared to the posterior-stabilized PFC Sigma RP in bilateral Subjects receiving both implants and if this difference is a function of implant design
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