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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

April 14, 2011
October 4, 2011
January 2003
March 2004   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01336595 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Device: Zirconium (Zirconium Genesis II)
    Oxidized Zirconium femoral component of Genesis II TKR system is used.
    Other Name: Zirconium Genesis II
  • Device: Cobalt-Chrome (Cobalt Chrome Genesis II)
    Cobalt Chrome Femoral Component of Genesis II TKR system is used
    Other Name: Cobalt Chrome Genesis II
  • Experimental: Zirconium Femoral Component
    Oxidized zirconium femoral component of Genesis II TKR system is used.
    Intervention: Device: Zirconium (Zirconium Genesis II)
  • Active Comparator: Cobalt Chrome
    Cobalt-Chromium Femoral component of Genesis II system is used.
    Intervention: Device: Cobalt-Chrome (Cobalt Chrome Genesis II)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
331
April 2011
March 2004   (final data collection date for primary outcome measure)

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
Both
30 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01336595
TKRzirconium
No
Young Hoo Kim, Ewha Womans University
Ewha Womans University
Not Provided
Principal Investigator: Jang-Won Park, MD Ewha Womans University Mokdong Hospital
Ewha Womans University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP