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Recruiting NCT05175300

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

No phase Interventional Hip Arthropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prosthesis with CoPXE couple., Prosthesis with CoC torque..
Who it may be relevant to
Registry conditions: Hip Arthropathy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • five-year wear thickness of the two friction pairs [Time frame: Year 5]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

France · 1 center
  • Hôpital Privé Jean Mermoz — Lyon

Identifiers

NCT: NCT05175300 · 2021-A02040-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗