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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763113
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Device: Vanguard PS Knee Device: Vanguard CR Knee Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Knee Society Score [ Time Frame: 6weeks, 6months, 1 year ]

Secondary Outcome Measures :
  1. WOMAC [ Time Frame: 6weeks, 6months, 1 year ]
  2. Oxford Knee [ Time Frame: 6weeks, 6months, 1 year ]
  3. Complication [ Time Frame: Anytime ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Patients need total knee replacement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763113


Locations
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Canada
St. Catharines Hospital
Ontario, Canada
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: David Martin, MD St. Catharines Hospital
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00763113    
Other Study ID Numbers: BMET CA 01
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017