A Prospective Randomized Study on Vanguard Cruciate Retaining Versus Vanguard High Flex Posterior Stabilized Total Knee System in the Early Range of Motion

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Device: Vanguard PS Knee; Device: Vanguard CR Knee

• Registration Number: NCT00763113
• Lead Sponsor: Zimmer Biomet

Brief Summary

Main Objectives are: Test Difference in terms of early ROM between Vanguard FB CR and Vanguard FB PS. Knees; Demonstrate the comparable ROM of high flex PS to CR.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-30
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vanguard PS Knee	Vanguard PS Knee
2	Vanguard CR Knee	Vanguard CR Knee

Primary Outcome Measures

Name	Time	Method
Knee Society Score	6weeks, 6months, 1 year

Secondary Outcome Measures

Name	Time	Method
WOMAC	6weeks, 6months, 1 year
Oxford Knee	6weeks, 6months, 1 year
Complication	Anytime

Trial Locations

Locations (1)

St. Catharines Hospital; 🇨🇦 Ontario, Canada