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

Primary Purpose

Arthroplasty Complications, Hip Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Highly Cross Linked Polyethylene and oxidized zirconium femoral head
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Arthroplasty Complications focused on measuring Hip arthroplasty, Tribology, wear

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Conventional Polyethylene versus metal head

Conventional Polyethylene versus oxidized zirconium head

Newer Cross linked Polyethylene metal head

Newer Cross linked Polyethylene versus oxidized zirconium head

Arm Description

This is the more conventional group bearing surfaces

This group uses the more conventional polyethylene against the newer head

In this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium)

In this group, we added both the new head and the new polyethylene

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survivorship of implant combinations
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

Full Information

First Posted
March 28, 2019
Last Updated
April 1, 2019
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03900039
Brief Title
An Assessment of 4 Different Bearing Types in Hip Replacement Types to Analsye the Lowest Wear Rates of Polyethylene
Official Title
Randomized Control Trial of Four Bearing Surfaces in Primary Total Hip Arthroplasty in Patients Over the Age of 18 Years
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 26, 2005 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
March 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty Complications, Hip Arthritis
Keywords
Hip arthroplasty, Tribology, wear

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Polyethylene versus metal head
Arm Type
Active Comparator
Arm Description
This is the more conventional group bearing surfaces
Arm Title
Conventional Polyethylene versus oxidized zirconium head
Arm Type
Experimental
Arm Description
This group uses the more conventional polyethylene against the newer head
Arm Title
Newer Cross linked Polyethylene metal head
Arm Type
Experimental
Arm Description
In this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium)
Arm Title
Newer Cross linked Polyethylene versus oxidized zirconium head
Arm Type
Experimental
Arm Description
In this group, we added both the new head and the new polyethylene
Intervention Type
Device
Intervention Name(s)
Highly Cross Linked Polyethylene and oxidized zirconium femoral head
Other Intervention Name(s)
Varilast - from Smith & Nephew
Intervention Description
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
Primary Outcome Measure Information:
Title
Wear rates of polyethylene over 10 years
Description
Linear and volumetric wear were measured in the most recent radiographs using a computer software package (Polyware Rev. 5; Draftware).
Time Frame
Over 10 years of wear rates
Secondary Outcome Measure Information:
Title
Survivorship of implant combinations
Description
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
Time Frame
over 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29212681
Citation
Atrey A, Ward SE, Khoshbin A, Hussain N, Bogoch E, Schemitsch EH, Waddell JP. Ten-year follow-up study of three alternative bearing surfaces used in total hip arthroplasty in young patients: a prospective randomised controlled trial. Bone Joint J. 2017 Dec;99-B(12):1590-1595. doi: 10.1302/0301-620X.99B12.BJJ-2017-0353.R1.
Results Reference
background
PubMed Identifier
30808529
Citation
Rames RD, Stambough JB, Pashos GE, Maloney WJ, Martell JM, Clohisy JC. Fifteen-Year Results of Total Hip Arthroplasty With Cobalt-Chromium Femoral Heads on Highly Cross-Linked Polyethylene in Patients 50 Years and Less. J Arthroplasty. 2019 Jun;34(6):1143-1149. doi: 10.1016/j.arth.2019.01.071. Epub 2019 Feb 5.
Results Reference
result

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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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