Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study

Not Applicable

Withdrawn

• Conditions: Osteoarthritis; Degenerative Arthritis
• Interventions: Device: Vanguard Knee System with PS Bearing; Device: Vanguard Knee System with AS Bearing

• Registration Number: NCT01308515
• Lead Sponsor: Zimmer Biomet

Brief Summary

The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-02
• Study Start: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterior Stabilized	Vanguard Knee System with PS Bearing	Patients who received a PS (Posterior Stabilized) Tibial Bearing.
Anterior Stablized	Vanguard Knee System with AS Bearing	Patients who received an AS (Anterior Stabilized) Tibial Bearing

Primary Outcome Measures

Name	Time	Method
Objective Knee Score	1 Year Post-op	Average objective knee score; includes a combination of range of motion and pain scores.

Secondary Outcome Measures

Name	Time	Method
Knee Society Score	3 Years	Average total knee score. Includes the objective and functional aspects of the knee score.
Dislocation	3 Years	Rate of Dislocation as reported by patients in a complication.
Reports of Radiographic Loosening via Complication Form	3 Years	A more specific survivorship element; will indicate rate of loosening if it occurs.
Survivorship	3 Years	Reports surivival of implant.