A Prospective Randomized Study on Vanguard Cruciate Retaining Versus Vanguard High Flex Posterior Stabilized Total Knee System in the Early Range of Motion
Sponsor
Zimmer Biomet (Industry)
Overall Status
Completed
CT.gov ID
NCT00763113
Collaborator
(none)
173
1
2
61
2.8
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
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
:
Jun 1, 2007
Actual Primary Completion Date
:
Jul 1, 2012
Actual Study Completion Date
:
Jul 1, 2012
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Knee Society Score [6weeks, 6months, 1 year]
Secondary Outcome Measures
- WOMAC [6weeks, 6months, 1 year]
- Oxford Knee [6weeks, 6months, 1 year]
- Complication [Anytime]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Patients need total knee replacement
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Catharines Hospital | Ontario | Canada |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Principal Investigator: David Martin, MD, St. Catharines Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT00763113
Other Study ID Numbers:
- BMET CA 01
First Posted:
Sep 30, 2008
Last Update Posted:
Jun 16, 2017
Last Verified:
Jun 1, 2017