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

March 6, 2013 updated by: Young Hoo Kim, Ewha Womans University

Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings in Primary Cementless Total Hip Arthroplasty in the Same Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Mokdong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous surgical history of hip

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ceramic on Ceramic
Ceramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty
Procedure: Ceramic on Ceramic bearing
cementless Total Hip Arthroplasty with Ceramic on ceramic bearing
Active Comparator: Ceramic on HXPE
Ceramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty
Procedure: Ceramic on Highly crosslinked polyethylene bearing
Cementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris hip score
Time Frame: Pre-op, last follow-up(11-13 years)
Comparing harris hip score before and after the intervention, and at the final follow-up, between two sides.
Pre-op, last follow-up(11-13 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Time Frame: preop, last follow-up(11-13 years)
WOMAC index before, and after the intervention, and between sides at the last follow-up
preop, last follow-up(11-13 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Investigators

  • Study Director: Young-Hoo Kim, MD, Ewha Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Primary Completion (Actual)

January 1, 2000

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Estimate)

March 7, 2013

Last Update Submitted That Met QC Criteria

March 6, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XPECCC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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