Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-30 @ 9:55 PM
Study NCT ID:
NCT01010269
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2009-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee
Status:
COMPLETED
Status Verified Date:
2018-06
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 compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.
Detailed Description:
The primary objectives of this clinical study include:
* Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
* Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
* Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:
* Early ROM
* Clinical outcomes
* Kinetic and Kinematic characteristics in relation to Healthy Knees. o
* Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :
* Early ROM
* Clinical outcomes
* Kinetic and Kinematic characteristics
* Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
* Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
* Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:
* Early ROM
* Clinical outcomes
* Kinetic and Kinematic characteristics in relation to Healthy Knees. o
* Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :
* Early ROM
* Clinical outcomes
* Kinetic and Kinematic characteristics
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?: