NCT01010269

Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study

A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Vanguard Complete Knee	Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
DEVICE	Vanguard High Flex RP	Vanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion.

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-10-01
• Completion: 2017-10-01
• First posted: 2009-11-10
• Last updated: 2018-06-26

Locations

4 sites across 1 country: South Korea