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

This study is ongoing, but not recruiting participants.

First Received on September 26, 2008. Last Updated on January 25, 2012 History of Changes

Sponsor:	Biomet, Inc.
Information provided by (Responsible Party):	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00763113

Purpose

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.

Condition	Intervention
Total Knee Arthroplasty	Device: Vanguard PS Knee Device: Vanguard CR Knee

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Knee Society Score [ Time Frame: 6weeks, 6months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

WOMAC [ Time Frame: 6weeks, 6months, 1 year ] [ Designated as safety issue: No ]
Oxford Knee [ Time Frame: 6weeks, 6months, 1 year ] [ Designated as safety issue: No ]
Complication [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]

Enrollment:	173
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Vanguard PS Knee	Device: Vanguard PS Knee Vanguard PS Knee
Active Comparator: 2 Vanguard CR Knee	Device: Vanguard CR Knee Vanguard CR Knee

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients need total knee replacement

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763113

Locations

Canada
St. Catharines Hospital
Ontario, Canada

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:

David Martin, MD

St. Catharines Hospital

More Information

No publications provided

Responsible Party:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00763113 History of Changes
Other Study ID Numbers:	BMET CA 01
Study First Received:	September 26, 2008
Last Updated:	January 25, 2012
Health Authority:	Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on February 09, 2012