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

Not Applicable

Active, not recruiting

• Conditions: Total Hip Arthroplasty
• Interventions: Device: Vitamin-E diffused polyethylene acetabular component; Device: Standard polyethylene acetabular component

• Registration Number: NCT02254980
• Lead Sponsor: Danderyd Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07
• Primary Completion: 2019-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin-E group	Vitamin-E diffused polyethylene acetabular component	Vitamin-E diffused polyethylene
Control group	Standard polyethylene acetabular component	Standard polyethylene

Primary Outcome Measures

Name	Time	Method
Cup migration	2 years	The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Orthopaedic department, Danderyd Hospital; 🇸🇪 Stockholm, Sweden