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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Hip Arthroplasty
- Sponsor
- Danderyd Hospital
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Cup migration
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Olof Skoldenberg
Consultant orthopedic surgeon
Danderyd Hospital
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Cup migration
Time Frame: 2 years
The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.
Secondary Outcomes
- Complication rate(10 years)
- Cup migration total(2 years)
- Linear wear(4 years)
- Functional outcome(2 years)
- Osteolysis(2 years)