An Assessment of 4 Different Bearing Types in Hip Replacement Types to Analsye the Lowest Wear Rates of Polyethylene

April 1, 2019 updated by: Unity Health Toronto

Randomized Control Trial of Four Bearing Surfaces in Primary Total Hip Arthroplasty in Patients Over the Age of 18 Years

The aim of the study is to assess the ideal bearing surfaces in hip replacement by comparing 4 different combinations. In a hip replacement this means what the head and the socket liner are made of.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In hip replacements, arguably the most important thing for survivorship is what rubs against what.

Traditionally surgeons used metal (Cobalt-Chrome) against a conventional polyethylene (plastic). More recently (around 15 years ago) a newer more dense type of polyethylene (called XLPE) had been developed and a new type of head called Oxidized Zirconium was also developed.

In this trial, adults who were undergoing hip replacements were randomized assigned into one of the four groups:

Group 1: old plastic vs metal head Group 2: Old plastic against Oxidized Zirconium Group 3: New plastic versus metal head Group 4 New plastic vs Oxidized Zirconium

All patients were followed up for a minimum of 10 years to assess which group wore the most amount of polyethylene and which group had the best survival rate.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's 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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adults with no history of cancer, infection of the hip and with the capacity to make informed consent for the trial

Exclusion Criteria:

  • those under the age of 18 and over 65. Those with a history of cancer and infection. Those without the capacity to make an informed consent.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Polyethylene versus metal head
This is the more conventional group bearing surfaces
Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Differing bearing surfaces:

  1. Conventional polyethylene versus cobalt Chrome heads
  2. Conventional polyethylene versus Oxidized Zirconium heads
  3. Highly Cross-linked polyethylene versus Cobalt Chrome heads
  4. Highly Cross-linked polyethylene versus Oxidized Zirconium heads
Other Names:
  • Varilast - from Smith & Nephew
Experimental: Conventional Polyethylene versus oxidized zirconium head
This group uses the more conventional polyethylene against the newer head
Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Differing bearing surfaces:

  1. Conventional polyethylene versus cobalt Chrome heads
  2. Conventional polyethylene versus Oxidized Zirconium heads
  3. Highly Cross-linked polyethylene versus Cobalt Chrome heads
  4. Highly Cross-linked polyethylene versus Oxidized Zirconium heads
Other Names:
  • Varilast - from Smith & Nephew
Experimental: Newer Cross linked Polyethylene metal head
In this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium)
Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Differing bearing surfaces:

  1. Conventional polyethylene versus cobalt Chrome heads
  2. Conventional polyethylene versus Oxidized Zirconium heads
  3. Highly Cross-linked polyethylene versus Cobalt Chrome heads
  4. Highly Cross-linked polyethylene versus Oxidized Zirconium heads
Other Names:
  • Varilast - from Smith & Nephew
Experimental: Newer Cross linked Polyethylene versus oxidized zirconium head
In this group, we added both the new head and the new polyethylene
Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Differing bearing surfaces:

  1. Conventional polyethylene versus cobalt Chrome heads
  2. Conventional polyethylene versus Oxidized Zirconium heads
  3. Highly Cross-linked polyethylene versus Cobalt Chrome heads
  4. Highly Cross-linked polyethylene versus Oxidized Zirconium heads
Other Names:
  • Varilast - from Smith & Nephew

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wear rates of polyethylene over 10 years
Time Frame: Over 10 years of wear rates
Linear and volumetric wear were measured in the most recent radiographs using a computer software package (Polyware Rev. 5; Draftware).
Over 10 years of wear rates

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survivorship of implant combinations
Time Frame: over 10 years
Assess linear and volumetric wear to assess if those bearing surfaces require to be revised (exchanged) during the experimental period in one group more than the others
over 10 years

Collaborators and Investigators

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

Sponsor

Unity Health Toronto

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)

July 26, 2005

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

March 26, 2019

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #04-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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