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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01336595

Enrollment

331

Registered

2011-04-18

Start date

2003-01-31

Completion date

2011-04-30

Last updated

2011-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

total knee arthroplasty, oxidized zirconium, genesis II, femoral component, cobalt chrome

Brief summary

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.

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.

Interventions

DEVICEZirconium (Zirconium Genesis II)

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

DEVICECobalt-Chrome (Cobalt Chrome Genesis II)

Cobalt Chrome Femoral Component of Genesis II TKR system is used

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement in Knee Society Knee Score	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

Measure	Time frame	Description
Improvement in the range of motion	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026