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Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty

RecruitingNAAges 55 Years - 80 YearsAllGCS Ramsay Santé pour l'Enseignement et la Recher…
NCT07207005 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery. The NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. The main reasons for these revisions include implant fractures, joint incompatibility, aseptic loosening, dislocation and wear of the polyethylene (PE) insert. To address this problem, highly cross-linked polyethylene (HXLPE) inserts have been developed. Cross-linking helps to limit wear on polyethylene prostheses in total hip arthroplasty. However, there are concerns about the loss of elasticity of HXLPE and oxidation after implantation. A new generation of inserts based on highly cross-linked polyethylene (irradiation dose ≥100 Kgy), enriched with vitamin E, has been develo

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient, male or female, aged between 55 and 80. * Patient with a life expectancy \> 5 years at the time of inclusion. * Patient scheduled to undergo primary total hip arthroplasty with a dual-mobility cup prosthesis. * Patient affiliated with or beneficiary of a social security scheme. * Patient who speaks French and has signed an informed consent form. Exclusion Criteria: * Patients with a contraindication mentioned in the instructions for use of the medical device under investigation * Patients with an ASA score of 4 * Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision * Patients participating in another clinical study whose objectives could interfere with this study
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What it tests

  • ECIMA CORIN
  • CORIN
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Where

1 site
Hôpital Privé Jean Mermoz
Lyon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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