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NCT00763113 Clinical Trial

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

Total Knee Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00763113
Other study ID # BMET CA 01
Secondary ID
Status Completed
Phase N/A
First received September 26, 2008
Last updated June 15, 2017
Start date June 2007
Est. completion date July 2012

Study information
Verified date June 2017
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 173
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Patients need total knee replacement

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Vanguard PS Knee
Vanguard PS Knee
• Vanguard CR Knee
Vanguard CR Knee

Locations
Country Name City State
Canada St. Catharines Hospital Ontario

Sponsors (1)
Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Knee Society Score 6weeks, 6months, 1 year
Secondary WOMAC 6weeks, 6months, 1 year
Secondary Oxford Knee 6weeks, 6months, 1 year
Secondary Complication Anytime
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