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

NCT05175300 | Recruiting

• 1 other identifier: 2021-A02040-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Arthropathy

Outcome Measures

Primary Outcomes (1)

• five-year wear thickness of the two friction pairs

  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

Study Arms (2)

Group 1

EXPERIMENTAL

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

Device: Prosthesis with CoPXE couple.

Group 2

ACTIVE COMPARATOR

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

Device: Prosthesis with CoC torque.

Interventions

Prosthesis with CoC torque. DEVICE

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

Group 2

Prosthesis with CoPXE couple. DEVICE

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

Group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

RECRUITING

MeSH Terms

Interventions

Prostheses and Implants

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Jean LANGLOIS, MD

CONTACT

0603294533; jeangast@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-centre, prospective, randomised, single-blind, comparative, category 2 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 Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: March 24, 2023
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)