Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208286
Status:
TERMINATED
Last Update Posted:
2016-06-20
First Post:
2005-09-13
Brief Title:
PFC Sigma Fixed Versus PFC RP Mobile Bearing Total Knee Systems
Sponsor:
DePuy International
Organization:
DePuy International
Study Overview
Official Title:
Clinical Evaluation of the PFC Sigma Fixed Bearing and PFC Sigma Rotating Platform Mobile Bearing Total Knee Systems
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary study outcome achieved investigator decided to conduct the study without sponsor support after 2009
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform RP knee systems The first patient had surgery on November 8 2001 and the final patient had surgery on July 29 2005 There were 120 knees consented by a single site which was the planned sample size in the study protocol with 117 receiving one of the study devices The study was terminated as the primary outcome was met and the investigator decided to conduct the study without sponsor support after 2009
Detailed Description:
Performance and safety will be assessed using the following surgeon and patient based outcome tools
1 American Knee Society Knee and Function Scores
2 Knee Society Radiological Analysis
3 Oxford Knee Score
4 SF 12 Score
5 Anterior Knee Pain Score
Specific objectives of the evaluation being to assess the following
1 Improvement in functional recovery
2 Incidence of anterior knee pain
3 Improvement in Quality of life
4 Incidence of tibial loosening
5 Incidence of excessive polyethylene wear
1 American Knee Society Knee and Function Scores
2 Knee Society Radiological Analysis
3 Oxford Knee Score
4 SF 12 Score
5 Anterior Knee Pain Score
Specific objectives of the evaluation being to assess the following
1 Improvement in functional recovery
2 Incidence of anterior knee pain
3 Improvement in Quality of life
4 Incidence of tibial loosening
5 Incidence of excessive polyethylene wear
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