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NCT Number: NCT05175300

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

Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location status: Recruiting

Location contact

Jean LANGLOIS, MD

CONTACT

[email protected]

0603294533 ext. 33

Jean LANGLOIS, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prosthesis with CoPXE couple.

Device

Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.

Prosthesis with CoC torque.

Device

Prosthesis with ceramic-on-ceramic (CoC) torque.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jean LANGLOIS, MD

CONTACT

[email protected]

0603294533 ext. 33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ICARE

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Jan 3, 2022
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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