Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components

October 4, 2011 updated by: Young Hoo Kim, Ewha Womans University

Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components in the Same Patients: A Prospective, Double Blinded, and Randomized Controlled Study

The purpose of this study is to determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although it has been claimed that total knee arthroplasties with an oxidized zirconium femoral knee component had beneficial wear properties in vitro, there are conflicting clinical results. The purpose of the present study was to compare the clinical, subjective, and radiographic results as well as the weight, size and shape of polyethylene wear particles in the patients with an oxidized zirconium and a cobalt-chromium femoral knee component.

Study Type

Interventional

Enrollment (Actual)

331

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zirconium Femoral Component
Oxidized zirconium femoral component of Genesis II TKR system is used.
Device: Zirconium (Zirconium Genesis II)
Oxidized Zirconium femoral component of Genesis II TKR system is used.
Other Names:
  • Zirconium Genesis II
Active Comparator: Cobalt Chrome
Cobalt-Chromium Femoral component of Genesis II system is used.
Device: Cobalt-Chrome (Cobalt Chrome Genesis II)
Cobalt Chrome Femoral Component of Genesis II TKR system is used
Other Names:
  • Cobalt Chrome Genesis II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Knee Society Knee Score
Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
change in knee score will be compared with initial score, until mean follow up of 20 years.
Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the range of motion
Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 20 years.
Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Investigators

  • Principal Investigator: Jang-Won Park, MD, Ewha Womans University Mokdong Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 18, 2011

Study Record Updates

Last Update Posted (Estimate)

October 5, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKRzirconium

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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