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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E
Patients will undergo total hip arthroplasty using a standard cemented acetabular component
Orthopaedic department, Danderyd Hospital
Stockholm, Sweden
Cup migration
The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.
Time frame: 2 years
Linear wear
Linear head penetration measured with RSA at 2 years
Time frame: 2 years
Linear wear
Linear head penetration measured with RSA at 4 years
Time frame: 4 years
Osteolysis
Development of radiolucent lines between bone and cement around the cup.
Time frame: 10 years
Osteolysis
Development of radiolucent lines between bone and cement around the cup.
Time frame: 2 years
Functional outcome
Hip function measured with Harris hip score
Time frame: 2 years
Complication rate
All hip-related complications and revision of implants
Time frame: 10 years
Cup migration total
Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM).
Time frame: 2 years
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