Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject (ICARE)

November 25, 2025 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A single-centre, prospective, randomised, single-blind, comparative study of two parallel groups of patients undergoing total hip arthroplasty:

  • Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
  • Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Locations

  • France
      • Lyon, France, 69008
        • Recruiting
        • Hopital Prive Jean Mermoz
        • Principal Investigator:
          • Jean LANGLOIS, MD
        • Contact:

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient aged 18 to 65 years,
  • Who have signed their consent to participate in the study,
  • For whom an indication for total hip arthroplasty has been given

Exclusion Criteria:

  • History of hip surgery
  • Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly)
  • Hip dysplasia
  • Inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis
  • Sequelae of neurological disease or stroke
  • Pregnant or breastfeeding women
  • Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
  • Patient likely not to return for follow-up visits
  • Patient already included in another therapeutic study protocol
  • Patient under court protection, guardianship or curatorship.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Device: Prosthesis with CoPXE couple.
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Active Comparator: Group 2
Prosthesis with ceramic-on-ceramic (CoC) torque.
Device: Prosthesis with CoC torque.
Prosthesis with ceramic-on-ceramic (CoC) torque.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
five-year wear thickness of the two friction pairs
Time Frame: Year 5
The primary endpoint is the five-year wear thickness of the two friction pairs (CoPXE versus CoC) after total hip arthroplasty. Wear thickness is the measurement of the penetration of the femoral head into the acetabular component. This measurement will be performed on frontal pelvic radiographs centred on the pubic symphysis using the semi-automatic computer-assisted technique described by Martell
Year 5

Collaborators and Investigators

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

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

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)

March 24, 2023

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02040-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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