NCT02254980

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Danderyd Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Hip Arthroplasty

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-02-01
• Primary completion: 2019-10-01
• Completion: 2026-10-01
• First posted: 2014-10-02
• Last updated: 2019-02-07

Locations

1 site across 1 country: Sweden