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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Polyethylene versus metal head | Active Comparator | This is the more conventional group bearing surfaces |
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| Conventional Polyethylene versus oxidized zirconium head | Experimental | This group uses the more conventional polyethylene against the newer head |
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| Newer Cross linked Polyethylene metal head | Experimental | In this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium) |
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| Newer Cross linked Polyethylene versus oxidized zirconium head | Experimental | In this group, we added both the new head and the new polyethylene |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Highly Cross Linked Polyethylene and oxidized zirconium femoral head | Device | Differing bearing surfaces:
|
| Measure | Description | Time Frame |
|---|---|---|
| Wear rates of polyethylene over 10 years | Linear and volumetric wear were measured in the most recent radiographs using a computer software package (Polyware Rev. 5; Draftware). | Over 10 years of wear rates |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship of implant combinations | 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 | over 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29212681 | Background | 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. | |
| 30808529 |
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The assessment of the implants was done by a secondary center that was unaware of which the bearing type was in which patient.
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| 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. |