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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 2019

Interventions

  • Device: Vitamin-E diffused polyethylene acetabular component
    • Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E
  • Device: Standard polyethylene acetabular component
    • Patients will undergo total hip arthroplasty using a standard cemented acetabular component

Arms, Groups and Cohorts

  • Experimental: Vitamin-E group
    • Vitamin-E diffused polyethylene
  • Active Comparator: Control group
    • Standard polyethylene

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Linear wear
    • Time Frame: 2 years
    • Linear head penetration measured with RSA at 2 years
  • Linear wear
    • Time Frame: 4 years
    • Linear head penetration measured with RSA at 4 years
  • Osteolysis
    • Time Frame: 10 years
    • Development of radiolucent lines between bone and cement around the cup.
  • Osteolysis
    • Time Frame: 2 years
    • Development of radiolucent lines between bone and cement around the cup.
  • Functional outcome
    • Time Frame: 2 years
    • Hip function measured with Harris hip score
  • Complication rate
    • Time Frame: 10 years
    • All hip-related complications and revision of implants
  • Cup migration total
    • Time Frame: 2 years
    • Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM).

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danderyd Hospital
  • Collaborator
    • Zimmer Biomet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Olof Skoldenberg, Consultant orthopedic surgeon – Danderyd Hospital

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