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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prosthesis with CoPXE couple.

    Device

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

  • Prosthesis with CoC torque.

    Device

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Active comparator 1 intervention

Trial outcomes

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

Time frame
Year 5

Secondary outcomes

Other outcomes

Sponsors and contacts

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