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The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acetabular polyethylene vitamys® | Active Comparator | acetabular polyethylene vitamys® |
|
| standard polyethylene acetabular irradiated at 3 Mrad | Active Comparator | standard polyethylene acetabular irradiated at 3 Mrad |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard polyethylene acetabular irradiated at 3 Mrad | Device |
| ||
| radio stereometric analysis (RSA) of the acetabular |
| Measure | Description | Time Frame |
|---|---|---|
| penetration of the metal femoral head in acetabular | head penetration in milimeters | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département d'orthopédie - traumatologie, CHU de Caen | Caen | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33263447 | Derived | Rochcongar G, Remazeilles M, Bourroux E, Dunet J, Chapus V, Feron M, Praz C, Buia G, Hulet C. Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial. Acta Orthop. 2021 Apr;92(2):151-155. doi: 10.1080/17453674.2020.1852785. Epub 2020 Dec 2. |
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| Other |
|
| acetabular polyethylene vitamys® | Device |
|