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Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement

Knee Osteoarthritis Clinical Trial

Official title:
Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System

Clinical Trial Summary

The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.

Clinical Trial Description

Due to excellent biocompatibility and wear characteristics, ceramics have a long history of success in total hip arthroplasty (THA). Use of a ceramic-polyethylene wear couple in total knee arthroplasty (TKA) has shown promising laboratory and early clinical results. The use of ceramics in this study is intended to address long-term failure of TKA due to osteolysis associated with polyethylene wear debris. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00743717
Study type Interventional
Source Kinamed Incorporated
Contact
Status Completed
Phase Phase 2
Start date February 2004
Completion date December 2012
View Details
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