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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Hip Arthropathy

Treatments: Device: Prosthesis with CoPXE couple.; Device: Prosthesis with CoC torque.

Study type: Interventional

Funder types: Other

Identifiers

NCT05175300

2021-A02040-41

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Device: Prosthesis with CoPXE couple.

Group 2

Active Comparator group

Description:

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

Treatment:

Device: Prosthesis with CoC torque.