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

NCT ID: NCT03900039

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-26

Study Completion Date

2019-03-26

Brief Summary

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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

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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.

Conditions

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Arthroplasty Complications Hip Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
The assessment of the implants was done by a secondary center that was unaware of which the bearing type was in which patient.

Study Groups

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Conventional Polyethylene versus metal head

This is the more conventional group bearing surfaces

Group Type ACTIVE_COMPARATOR

Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Intervention Type DEVICE

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

Conventional Polyethylene versus oxidized zirconium head

This group uses the more conventional polyethylene against the newer head

Group Type EXPERIMENTAL

Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Intervention Type DEVICE

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

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)

Group Type EXPERIMENTAL

Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Intervention Type DEVICE

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

Newer Cross linked Polyethylene versus oxidized zirconium head

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

Group Type EXPERIMENTAL

Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Varilast - from Smith & Nephew

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 29212681 (View on PubMed)

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.

Reference Type RESULT
PMID: 30808529 (View on PubMed)

Other Identifiers

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#04-025

Identifier Type: -

Identifier Source: org_study_id

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