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

Not Applicable

Recruiting

• Conditions: Hip Arthropathy

• Registration Number: NCT05175300
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

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 Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-03
• Study Start: 2023-03-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2030-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Hôpital Privé Jean Mermoz; 🇫🇷 Lyon, France