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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00763113
First received: September 26, 2008
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  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
Study Completion Date: July 2012
Primary Completion Date: July 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: July 12, 2012
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on May 23, 2013