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

NCT ID: NCT01336595

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Zirconium Femoral Component

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

Group Type EXPERIMENTAL

Zirconium (Zirconium Genesis II)

Intervention Type DEVICE

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

Cobalt Chrome

Cobalt-Chromium Femoral component of Genesis II system is used.

Group Type ACTIVE_COMPARATOR

Cobalt-Chrome (Cobalt Chrome Genesis II)

Intervention Type DEVICE

Cobalt Chrome Femoral Component of Genesis II TKR system is used

Interventions

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Zirconium (Zirconium Genesis II)

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

Intervention Type DEVICE

Cobalt-Chrome (Cobalt Chrome Genesis II)

Cobalt Chrome Femoral Component of Genesis II TKR system is used

Intervention Type DEVICE

Other Intervention Names

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Zirconium Genesis II Cobalt Chrome Genesis II

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Young Hoo Kim

Professor and Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jang-Won Park, MD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Locations

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Ewha Womans University Mokdong Hosptial

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Ezzet KA, Hermida JC, Colwell CW Jr, D'Lima DD. Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin Orthop Relat Res. 2004 Nov;(428):120-4. doi: 10.1097/01.blo.0000148576.70780.13.

Reference Type BACKGROUND
PMID: 15534531 (View on PubMed)

Good V, Ries M, Barrack RL, Widding K, Hunter G, Heuer D. Reduced wear with oxidized zirconium femoral heads. J Bone Joint Surg Am. 2003;85-A Suppl 4:105-10. doi: 10.2106/00004623-200300004-00013. No abstract available.

Reference Type BACKGROUND
PMID: 14652400 (View on PubMed)

Other Identifiers

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TKRzirconium

Identifier Type: -

Identifier Source: org_study_id