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

June 15, 2017 updated by: Zimmer Biomet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Ontario, Canada
        • St. Catharines Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients need total knee replacement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Society Score
Time Frame: 6weeks, 6months, 1 year
6weeks, 6months, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
WOMAC
Time Frame: 6weeks, 6months, 1 year
6weeks, 6months, 1 year
Oxford Knee
Time Frame: 6weeks, 6months, 1 year
6weeks, 6months, 1 year
Complication
Time Frame: Anytime
Anytime

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Principal Investigator: David Martin, MD, St. Catharines Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (ESTIMATE)

September 30, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • BMET CA 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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