Clinical Trials Directory

Trials / Completed

CompletedNCT03900039

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

Randomized Control Trial of Four Bearing Surfaces in Primary Total Hip Arthroplasty in Patients Over the Age of 18 Years

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Unity Health Toronto · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEHighly Cross Linked Polyethylene and oxidized zirconium femoral headDiffering 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

Timeline

Start date
2005-07-26
Primary completion
2018-07-26
Completion
2019-03-26
First posted
2019-04-02
Last updated
2019-04-02

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03900039. Inclusion in this directory is not an endorsement.