Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings

NCT ID: NCT01806766

Last Updated: 2013-03-07

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and active patients.

Detailed Description

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Conditions

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Osteonecrosis Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ceramic on Ceramic

Ceramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty

Group Type ACTIVE_COMPARATOR

Ceramic on Ceramic bearing

Intervention Type PROCEDURE

cementless Total Hip Arthroplasty with Ceramic on ceramic bearing

Ceramic on HXPE

Ceramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty

Group Type ACTIVE_COMPARATOR

Ceramic on Highly crosslinked polyethylene bearing

Intervention Type PROCEDURE

Cementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing

Interventions

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Ceramic on Ceramic bearing

cementless Total Hip Arthroplasty with Ceramic on ceramic bearing

Intervention Type PROCEDURE

Ceramic on Highly crosslinked polyethylene bearing

Cementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Primary hip osteoarthritis
* Secondary hip osteoarthritis
* Avascular necrosis of femoral head

Exclusion Criteria

* Previous surgical history of hip
Minimum Eligible Age

18 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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Hoo Kim, MD

Role: STUDY_DIRECTOR

Ewha Womans University Mokdong Hospital

Locations

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Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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XPECCC

Identifier Type: -

Identifier Source: org_study_id

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