An Assessment of 4 Different Bearing Types in Hip Replacement Types to Analsye the Lowest Wear Rates of Polyethylene
NCT ID: NCT03900039
Last Updated: 2019-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2005-07-26
2019-03-26
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Conventional Polyethylene versus metal head
This is the more conventional group bearing surfaces
Highly 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
Conventional Polyethylene versus oxidized zirconium head
This group uses the more conventional polyethylene against the newer head
Highly 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
Newer Cross linked Polyethylene metal head
In this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium)
Highly 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
Newer Cross linked Polyethylene versus oxidized zirconium head
In this group, we added both the new head and the new polyethylene
Highly 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
Interventions
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Highly 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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Atrey A, Ward SE, Khoshbin A, Hussain N, Bogoch E, Schemitsch EH, Waddell JP. Ten-year follow-up study of three alternative bearing surfaces used in total hip arthroplasty in young patients: a prospective randomised controlled trial. Bone Joint J. 2017 Dec;99-B(12):1590-1595. doi: 10.1302/0301-620X.99B12.BJJ-2017-0353.R1.
Rames RD, Stambough JB, Pashos GE, Maloney WJ, Martell JM, Clohisy JC. Fifteen-Year Results of Total Hip Arthroplasty With Cobalt-Chromium Femoral Heads on Highly Cross-Linked Polyethylene in Patients 50 Years and Less. J Arthroplasty. 2019 Jun;34(6):1143-1149. doi: 10.1016/j.arth.2019.01.071. Epub 2019 Feb 5.
Other Identifiers
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#04-025
Identifier Type: -
Identifier Source: org_study_id
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