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Polyethylene Wear Particle Analysis of TKA

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 1 to 2v3
  2. Study description expanded, about 20 words
    • Study title expanded, about 1 word
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study was to investigate whether polyethylene (Vitamin E-containing polyethylene), which has been newly introduced and widely used clinically as a biomaterial for tibial inserts in total knee arthroplasty, but whose mid- to long-term clinical results are still unknown, is more effective than conventional polyethylene. Our goal is to clarify through an international multi-center joint study using in vivo polyethylene wear particle analysis, which the investigators developed as a method to provide early feedback, as to whether polyethylene wear debris production in vivo can be reduced.
Trial Details
NCT Number NCT06426641
Lead Sponsor Osaka Metropolitan University
Collaborators: Mayo Clinic, Istituto Ortopedico Rizzoli, Hospital for Special Surgery, New York
Conditions
(from sponsor)		 Wear of Articular Bearing Surface of Prosthetic Joint, Total Knee Arthroplasty
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov