NCT00743717

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Kinamed Incorporated · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	zirconia femoral component	total knee arthroplasty performed using implant with zirconia femoral component
DEVICE	cobalt chrome femoral component	total knee arthroplasty performed using implant with cobalt chrome femoral component

Timeline

• Start date: 2004-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-08-29
• Last updated: 2013-05-27
• Results posted: 2013-05-22