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Polyethylene Wear Particle Analysis of THA

NCT06432543 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-01-20

No results posted yet for this study

Summary

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.

Conditions

  • Wear of Articular Bearing Surface of Prosthetic Joint
  • Hip Arthropathy

Interventions

DEVICE

polyethylene

No intervention as this is an observational study

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Hospital for Special Surgery, New York

    collaborator OTHER

  • Istituto Ortopedico Rizzoli

    collaborator OTHER

  • Osaka Metropolitan University

    lead OTHER

Principal Investigators

  • Yukihide Minoda, MD, PhD · Osaka Metropolitan University

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States
  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06432543 on ClinicalTrials.gov