Randomized Control Trial of Four Bearing Surfaces in Primary Total Hip Arthroplasty in Patients Over the Age of 18 Years
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthroplasty Complications
- Sponsor
- Unity Health Toronto
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Wear rates of polyethylene over 10 years
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •Those with a history of cancer and infection. Those without the capacity to make an informed consent.
Outcomes
Primary Outcomes
Wear rates of polyethylene over 10 years
Time Frame: 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 Outcomes
- Survivorship of implant combinations(over 10 years)