NCT00763113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

5.1 years

First QC Date

September 26, 2008

Last Update Submit

June 15, 2017

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Knee Society Score

    6weeks, 6months, 1 year

Secondary Outcomes (3)

  • WOMAC

    6weeks, 6months, 1 year

  • Oxford Knee

    6weeks, 6months, 1 year

  • Complication

    Anytime

Study Arms (2)

1

EXPERIMENTAL

Vanguard PS Knee

Device: Vanguard PS Knee

2

ACTIVE COMPARATOR

Vanguard CR Knee

Device: Vanguard CR Knee

Interventions

Vanguard PS KneeDEVICE

Vanguard PS Knee

1
Vanguard CR KneeDEVICE

Vanguard CR Knee

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patients need total knee replacement

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Catharines Hospital

Ontario, Canada

Location

Study Officials

  • David Martin, MD

    St. Catharines Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

June 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

CA(1)