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

Unity Health Toronto

Status: Completed

Conditions: Hip Arthritis; Arthroplasty Complications

Treatments: Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Study type: Interventional

Funder types: Other

Identifiers

NCT03900039

#04-025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Conventional Polyethylene versus metal head

Active Comparator group

Description:

This is the more conventional group bearing surfaces

Treatment:

Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Conventional Polyethylene versus oxidized zirconium head

Experimental group

Description:

This group uses the more conventional polyethylene against the newer head

Treatment:

Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Newer Cross linked Polyethylene metal head

Experimental group

Description:

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

Treatment:

Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Newer Cross linked Polyethylene versus oxidized zirconium head

Experimental group

Description:

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

Treatment:

Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head