Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study (VGASPS)
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|ClinicalTrials.gov Identifier: NCT01308515|
Recruitment Status : Withdrawn (Could not find interested researchers/clinicians to complete study protocol.)
First Posted : March 4, 2011
Last Update Posted : June 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Degenerative Arthritis||Device: Vanguard Knee System with AS Bearing Device: Vanguard Knee System with PS Bearing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||September 2010|
Patients who received a PS (Posterior Stabilized) Tibial Bearing.
Device: Vanguard Knee System with PS Bearing
FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.
Patients who received an AS (Anterior Stabilized) Tibial Bearing
Device: Vanguard Knee System with AS Bearing
FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.
- Objective Knee Score [ Time Frame: 1 Year Post-op ]Average objective knee score; includes a combination of range of motion and pain scores.
- Knee Society Score [ Time Frame: 3 Years ]Average total knee score. Includes the objective and functional aspects of the knee score.
- Dislocation [ Time Frame: 3 Years ]Rate of Dislocation as reported by patients in a complication.
- Survivorship [ Time Frame: 3 Years ]Reports surivival of implant.
- Reports of Radiographic Loosening via Complication Form [ Time Frame: 3 Years ]A more specific survivorship element; will indicate rate of loosening if it occurs.
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): NCT01308515
|Study Director:||Ken Beres, MD||Biomet (no investigators were selected for this study)|