Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty (E1-hip)

February 6, 2019 updated by: Olof Skoldenberg, Danderyd Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 18288
        • Orthopaedic department, Danderyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin-E group
Vitamin-E diffused polyethylene
Device: Vitamin-E diffused polyethylene acetabular component
Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E
Active Comparator: Control group
Standard polyethylene
Device: Standard polyethylene acetabular component
Patients will undergo total hip arthroplasty using a standard cemented acetabular component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Collaborators

Zimmer Biomet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2026

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Actual)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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