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

Study acronym: CUPUSURE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 4 months later Aug 31, 2036 → Dec 31, 2038
See other at-risk trials from GCS Ramsay Santé pour l'Enseignement et la Recherche

Record History

  1. Notable Primary and study completion pushed from Aug 31, 2036 to Dec 31, 2038
    • Recruitment opened
    • Start date changed from estimate of Nov 15, 2025 to Jul 30, 2026
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 developed. This PE, called ECIMA, was developed to maintain mechanical properties, minimise PE wear and improve long-term oxidation resistance. In the HAS evaluation report on highly cross-linked polyethylene inserts dated 24 January 2023, data from the literature show less wear of highly cross-linked polyethylene compared to conventional polyethylene. Nevertheless, the use of highly cross-linked polyethylene is not yet the gold standard. Furthermore, the data in the literature mainly concern single-mobility cups but not double-mobility cups. Finally, new imaging protocols now make it possible to assess the wear of prosthesis materials more accurately. In this context, it seems appropriate to conduct a French study comparing double-mobility cups containing highly cross-linked polyethylene or conventional polyethylene inserts.
Trial Details
NCT Number NCT07207005
Lead Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions
(from sponsor)
Hip Arthroplasty Replacement
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov