Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty

Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup Compared to Standard Cemented Cup in Total Hip Arthroplasty. A Randomized, Single-blinded, Clinical Trial

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.

Inclusion Criteria:

• Primary osteoarthritis of the hip
• Willingness and ability to follow study-protocol

Exclusion Criteria:

• Inflammatory arthritis or secondary osteoarthritis.
• Type C (stove pipe) femur
• Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation of components
• Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
• Ongoing oestrogen treatment
• Not suited for the study for other reason (surgeons preference)