Ceramic-on-Ceramic Versus Ceramic-on-HXLPE THA

August 19, 2018 updated by: Young Hoo Kim, Ewha Womans University

Is Ceramic-on-Ceramic THA Superior to Ceramic-on-Highly Cross-Linked Polyethylene THA in Patients Less Than 55 Years Old?

Methods to reduce the revision rate of total hip arthroplasties (THAs) because of wear-related issues are important to examine, particularly because younger patients have a disproportionately high risk of revision. The investigators hoped to follow up patients and see if long-term Harris hip scores and WOMAC scores better in younger patients with a ceramic-on-ceramic (COC) THA compared with those with a ceramic-on-highly-cross-linked polyethylene (COP) THA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

High success rates obtained in the general population have stimulated for total hip arthroplasty (THA) in young and active patients. Although there have been substantial improvements in THA, bearing surface wear and osteolysis are major factors limiting the durability of THAs in young and active patients. During the last decade, alternative bearings have been developed, including highly cross-linked polyethylene (HXLPE) and ceramic-on-ceramic (COC) bearings, with the potential to reduce wear and osteolysis in younger, more active patients.

Despite contemporary cementless THA with COC bearings giving excellent clinical and radiographic outcomes, there is concern about squeaking, fracture of the ceramic head or acetabular insert or fretting and corrosion (trunnionosis). Although HXLPE have been reported to reduce polyethylene wear, there is concerned about a potential decrease in toughness, tensile strength and resistance to the propagation of fatigue cracks in a long-term follow-up.

Several noncomparative studies of COC and COP THA have reported promising results in terms of Harris hip scores, radiographic findings, and survival rates, yet we are aware of no long-term comparative clinical studies with a COC THA and a COP THA in the same younger patients. This study aimed to see if long-term Harris hip scores and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score better in younger patients with a COC THA compared with those with a COP THA.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 4

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • bilateral end-stage hip arthrosis

Exclusion Criteria:

  • inflammatory arthritis, foot and ankle disorders, dementia, stroke history, high dislocation of hip, patients older than 55 years

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COC
for the arthritic hip of the patient, total hip arthroplasty(THA) with ceramic on ceramic(COC) bearing couple is implanted. The group with intervention COC THA.
Procedure: COC THA
standard total hip arthroplasty is done, with ceramic on ceramic for the bearing.
Active Comparator: COP
for the arthritic hip of the patient, total hip arthroplasty(THA) with ceramic on highly cross-linked polyethylene bearing couple is implanted. The group with intervention COP THA.
Procedure: COP THA
standard total hip arthroplasty is done, with ceramic on highly cross linked polyethylene for the bearing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris hip score
Time Frame: 15 years after the intervention
The Harris Hip Score(HHS) was developed by William H. Harris to assess the results of hip surgery or hip replacement. The standard evaluation applies to various hip disabilities and methods of treatment in adults. The original version of the score was first published in 1969. 100 is the best score, and 0 is the worst possible score. HHS has a subset of pain(44 points), function(47 points), absence of deformity(4 points), and range of motion(5 points)
15 years after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC(Western Ontario and McMaster Universities) Scores
Time Frame: 15 years after the intervention
A tool to evaluate patient function associated with knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total score is summed from individual sections, and 0 is the best possible score.
15 years after the intervention

Collaborators and Investigators

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

Sponsor

Ewha Womans University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2000

Primary Completion (Actual)

April 30, 2003

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 19, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 19, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HXLTHA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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