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Completed

NCT Number: NCT01336595

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ewha Womans University Mokdong Hosptial

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zirconium (Zirconium Genesis II)

Device

Oxidized Zirconium femoral component of Genesis II TKR system is used.

Other names: Zirconium Genesis II

Cobalt-Chrome (Cobalt Chrome Genesis II)

Device

Cobalt Chrome Femoral Component of Genesis II TKR system is used

Other names: Cobalt Chrome Genesis II

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2011
First posted
Apr 18, 2011
Registry last updated
Oct 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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