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

Sponsor
Unity Health Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT03900039
Collaborator
(none)
100
Enrollment
1
Location
4
Arms
164
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The assessment of the implants was done by a secondary center that was unaware of which the bearing type was in which patient.
Primary Purpose:
Health Services Research
Official Title:
Randomized Control Trial of Four Bearing Surfaces in Primary Total Hip Arthroplasty in Patients Over the Age of 18 Years
Actual Study Start Date :
Jul 26, 2005
Actual Primary Completion Date :
Jul 26, 2018
Actual Study Completion Date :
Mar 26, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Wear rates of polyethylene over 10 years [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).

    Secondary Outcome Measures

    1. Survivorship of implant combinations [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Michael's Hospital Toronto Ontario Canada M5B 1W8

    Sponsors and Collaborators

    • Unity Health Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Unity Health Toronto
    ClinicalTrials.gov Identifier:
    NCT03900039
    Other Study ID Numbers:
    • #04-025
    First Posted:
    Apr 2, 2019
    Last Update Posted:
    Apr 2, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Unity Health Toronto
    Hip arthroplasty
    Tribology
    wear
    Additional relevant MeSH terms:
    Arthritis

    Study Results

    No Results Posted as of Apr 2, 2019