Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

Status Completed

Clinical Trial Summary

This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components.

Clinical Trial Description

This study is designed to evaluate the safety and efficacy of Vanguard™ Deep Dish Rotating Platform Knee (mobile bearing knee) as compared to Vanguard Cruciate Retaining Knee (fixed bearing knee). This trial will be conducted as the randomised, controlled study. Implant loosening and polyethylene wear in fixed-bearing knee prostheses were recognized as major causes of late failure. The mobile bearing knee have the theoretical advantages of potentially minimizing the polyethylene wear and reducing implant to bone interface stress in order to reduce the incidence of implant loosening. Therefore, the aims of this study are to prove the Vanguard deep dish rotating platform knee is at least as effective in clinical outcome as the widely used current design of knee replacement and better in long term survivorship. The efficacy of the device will be determined by the relief of pain, restoration of function and range of motion. The durability of device will be determined by the absence of revision/removal and radiological integrity. To assess the safety of the device, all post operative complications will be recorded either device related or otherwise. Patient satisfaction as determined by answers to patient outcome questionnaires (Oxford Knee Score, WOMAC and Lower Extremity Activity Scale). ;

Study Design

Related Conditions & MeSH terms

Osteoarthritis

Clinical Trial Details

NCT number	NCT00753090
Study type	Interventional
Source	Zimmer Biomet
Contact
Status	Completed
Phase	N/A
Start date	June 2009
Completion date	July 15, 2022

View Details

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