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

Not Applicable

Completed

• Conditions: Hip Arthritis; Arthroplasty Complications
• Interventions: Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

• Registration Number: NCT03900039
• Lead Sponsor: Unity Health 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.

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 Timeline

• Study Start: 2005-07-26
• Primary Completion: 2018-07-26
• Study Completion: 2019-03-26
• Study First Submitted: 2019-03-28
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-01
• Last Update Submitted: 2019-04-01
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Newer Cross linked Polyethylene metal head	Highly Cross Linked Polyethylene and oxidized zirconium femoral head	In this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium)
Newer Cross linked Polyethylene versus oxidized zirconium head	Highly Cross Linked Polyethylene and oxidized zirconium femoral head	In this group, we added both the new head and the new polyethylene
Conventional Polyethylene versus metal head	Highly Cross Linked Polyethylene and oxidized zirconium femoral head	This is the more conventional group bearing surfaces
Conventional Polyethylene versus oxidized zirconium head	Highly Cross Linked Polyethylene and oxidized zirconium femoral head	This group uses the more conventional polyethylene against the newer head

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada