CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
zirconia femoral component +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00743717
NCT00743717Phase 2Completed
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Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System

Kinamed Incorporated·interventional·Posted Aug 29, 2008·Updated May 27, 2013

In Brief

A Phase 2 clinical trial evaluating zirconia femoral component and cobalt chrome femoral component for Knee Osteoarthritis. Completed, enrolled 4 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2008
Enrollment StartFeb 1, 2004
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 17.8 years ago

Interventions

zirconia femoral componentdevice

total knee arthroplasty performed using implant with zirconia femoral component

cobalt chrome femoral componentdevice

total knee arthroplasty performed using implant with cobalt chrome femoral component