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Post Market Study of the 3DKnee™ With E-plus Insert — e-plus  

Osteoarthritis Clinical Trial

Official title:
Prospective Multicenter Open Label Study Examining the Mid- and Long-term Safety and Efficacy of the 3DKnee™ System With Vitamin E UHMWPE Tibial Inserts (3DKnee™ With E-plus Insert)

Clinical Trial Summary

The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery.

Clinical Trial Description

Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. Currently available prosthetic designs accomplish these goals and the surgery has been defined as one of the most successful operations available to improve the quality of life for patients with DJD. This study will evaluate subjects who are candidates for a total knee replacement and meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01551472
Study type Observational
Source Encore Medical, L.P.
Contact
Status Terminated
Phase
Start date April 2012
Completion date January 2022
View Details
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