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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE although several trials are ongoing. All of these trials use uncemented acetabular cups intended for biological fixation. In many countries the standard fixation method for the acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation when used in acetabular components. The aim of the study is to compare migration, linear wear and clinical results between two types of cemented acetabular cups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin-E group | Experimental | Vitamin-E diffused polyethylene |
|
| Control group | Active Comparator | Standard polyethylene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin-E diffused polyethylene acetabular component | Device | Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cup migration | The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Linear wear | Linear head penetration measured with RSA at 2 years | 2 years |
| Linear wear | Linear head penetration measured with RSA at 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic department, Danderyd Hospital | Stockholm | 18288 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27388352 | Derived | Skoldenberg O, Rysinska A, Chammout G, Salemyr M, Muren O, Boden H, Eisler T. Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP). BMJ Open. 2016 Jul 7;6(7):e010781. doi: 10.1136/bmjopen-2015-010781. |
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| Standard polyethylene acetabular component | Device | Patients will undergo total hip arthroplasty using a standard cemented acetabular component |
|
| 4 years |
| Osteolysis | Development of radiolucent lines between bone and cement around the cup. | 10 years |
| Osteolysis | Development of radiolucent lines between bone and cement around the cup. | 2 years |
| Functional outcome | Hip function measured with Harris hip score | 2 years |
| Complication rate | All hip-related complications and revision of implants | 10 years |
| Cup migration total | Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM). | 2 years |