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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vitamin-E group

Vitamin-E diffused polyethylene

Group Type EXPERIMENTAL

Vitamin-E diffused polyethylene acetabular component

Intervention Type DEVICE

Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E

Control group

Standard polyethylene

Group Type ACTIVE_COMPARATOR

Standard polyethylene acetabular component

Intervention Type DEVICE

Patients will undergo total hip arthroplasty using a standard cemented acetabular component

Interventions

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Vitamin-E diffused polyethylene acetabular component

Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E

Intervention Type DEVICE

Standard polyethylene acetabular component

Patients will undergo total hip arthroplasty using a standard cemented acetabular component

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No