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

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ClinicalTrials.gov Identifier: NCT03900039
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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
Arthroplasty Complications Hip Arthritis Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : July 26, 2005
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Varilast - from Smith & Nephew




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900039


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto

Publications of Results:
Other Publications:
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03900039     History of Changes
Other Study ID Numbers: #04-025
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 St. Michael's Hospital, Toronto:
Hip arthroplasty
Tribology
wear