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
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Brief Summary
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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
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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.

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

Conditions
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Hip Arthropathy

Intervention / Treatment
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* Device: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
* Device: Prosthesis with ceramic-on-ceramic (CoC) torque.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |