Clinical Trial

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

Study acronym: E1-hip

Active, Not Recruiting

Record status

This record was last updated February 7, 2019 (before its estimated October 2019 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2014-10-01; most recent amendment 2019-02-06.

Status change: Recruiting → Active, Not Recruiting 2019-02-06

Trial Details

NCT Number	NCT02254980
Lead Sponsor	Danderyd Hospital Collaborators: Zimmer Biomet
Conditions	Total Hip Arthroplasty
Enrollment	44 participants
Start Date	2013-02
Primary Completion	2019-10 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2019-02-07