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

NCT00743717 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2013-05-27

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Kinamed Incorporated

    lead INDUSTRY

Principal Investigators

  • Vineet Sarin, PhD · Kinamed Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2012-12-31
Completion
2012-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00743717 on ClinicalTrials.gov