Arthroplasty Complications, Hip Arthritis
Conditions
Keywords
Hip arthroplasty, Tribology, wear
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.
Interventions
DEVICEHighly 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
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed