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Clinical Trials/NCT02254980
NCT02254980
Active, not recruiting
Not Applicable

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

Danderyd Hospital1 site in 1 country44 target enrollmentFebruary 2013

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
October 2026
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Danderyd Hospital
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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