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

NCT05175300 · tracked via the Priya Life Science France tracker

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Phase

Not applicable

Started

2023-03-24

Last updated

2025-12-03

Condition(s) studied

Hip Arthropathy

Investigational drug(s) / intervention(s)

Prosthesis with CoPXE couple.Prosthesis with CoC torque.

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

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

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

five-year wear thickness of the two friction pairs — 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

Trial sites (1)

Facility	City	Region	Status
Hôpital Privé Jean Mermoz	Lyon	France	Recruiting

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Other trials for the same condition

Post Market Clinical Follow-up of EUROSTEM Femoral Stem Active, not recruiting

Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE Active, not recruiting

Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup Active, not recruiting

Hip Prospective Study Recruiting

Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05175300 on ClinicalTrials.gov ↗ ← All trials in France