Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty (E1-hip)

Danderyd Hospital

Status

Active, not recruiting

Conditions

Total Hip Arthroplasty

Treatments

Device: Vitamin-E diffused polyethylene acetabular component

Device: Standard polyethylene acetabular component

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02254980

E1-H

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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)