Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement (POLYTITAN)

September 10, 2018 updated by: University Hospital, Caen
The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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

  • France
      • Caen, France, 14000
        • Département d'orthopédie - traumatologie, CHU de Caen

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged men and women 18 to 75 years
  • with a primary or secondary osteoarthritis or osteonecrosis
  • having a functional disorder requiring the installation of a total hip prosthesis of primary

Exclusion Criteria:

  • patients aged 76 years or more
  • pregnant or desiring to be for the duration of the study
  • minors or adults protected
  • repeated hip replacement
  • cephalic prosthesis recovery or intermediate
  • repeated cupules
  • primary or secondary malignant tumor of the hip

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: acetabular polyethylene vitamys®
Other: radio stereometric analysis (RSA) of the acetabular
Device: acetabular polyethylene vitamys®
Active Comparator: standard polyethylene acetabular irradiated at 3 Mrad
Other: radio stereometric analysis (RSA) of the acetabular
Device: standard polyethylene acetabular irradiated at 3 Mrad

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
penetration of the metal femoral head in acetabular
Time Frame: 2 years
head penetration in milimeters
2 years

Collaborators and Investigators

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

Sponsor

University Hospital, Caen

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 (Actual)

January 1, 2010

Primary Completion (Actual)

November 1, 2016

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 09-113

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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