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Polyethylene Wear Particle Analysis of THA

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v3
  2. Study description expanded, about 14 wordsv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Purpose of research The purpose of this study was to demonstrate that polyethylene (Vitamin E-containing polyethylene), a newly introduced biomaterial for tibial inserts in hip replacement surgery and widely used clinically, but whose mid- to long-term clinical results are still unknown, is superior to conventional polyethylene in vivo. The aim of this project is to conduct an international multi-center joint research study to determine whether polyethylene wear debris production can be reduced in the future, using an in vivo polyethylene wear debris analysis method that the investigators developed as a method that can provide early feedback.
Trial Details
NCT Number NCT06432543
Lead Sponsor Osaka Metropolitan University
Collaborators: Mayo Clinic, Hospital for Special Surgery, New York, Istituto Ortopedico Rizzoli
Conditions
(from sponsor)		 Wear of Articular Bearing Surface of Prosthetic Joint, Hip Arthropathy
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov