Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Young Hoo Kim, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01336595
First received: April 14, 2011
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
 Device: Zirconium (Zirconium Genesis II)
Device: Cobalt-Chrome (Cobalt Chrome Genesis II)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Zirconium
U.S. FDA Resources

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Improvement in Knee Society Knee Score [ Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery ] [ Designated as safety issue: No ]
    change in knee score will be compared with initial score, until mean follow up of 20 years.


Secondary Outcome Measures:
  • Improvement in the range of motion [ Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery ] [ Designated as safety issue: No ]
    change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 20 years.


Enrollment: 331
Study Start Date: January 2003
Study Completion Date: April 2011
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Cobalt Chrome Genesis II

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.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336595

Locations
Korea, Republic of
Ewha Womans University Mokdong Hosptial
Seoul, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: Jang-Won Park, MD Ewha Womans University
  More Information

Publications:

Responsible Party: Young Hoo Kim, Professor and Director, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01336595     History of Changes
Other Study ID Numbers: TKRzirconium
Study First Received: April 14, 2011
Last Updated: October 4, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ewha Womans University:
total knee arthroplasty
oxidized zirconium
genesis II
femoral component
cobalt chrome

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Chromium
 Cobalt
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013