Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:03 PM
Study NCT ID:
NCT00764803
Status:
TERMINATED
Last Update Posted:
2010-03-11
First Post:
2008-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3DKnee™ System vs. the MJS Knee System
Sponsor:
Encore Medical, L.P.
Organization:
Study Overview
Official Title:
Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Corporate decision to discontinue distribution of MJS Knee.
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 compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way.
Detailed Description:
The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.
Study Oversight
Has Oversight DMC:
False
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?: