RecruitingNCT06432543

Polyethylene Wear Particle Analysis of THA

Polyethylene Wear Particle Analysis of Total Hip Arthroplasty -International Multicenter Study-


Sponsor

Osaka Metropolitan University

Enrollment

90 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Inclusion Criteria4

  • Patients undergoing revision hip arthroplasty within the study period
  • Patients over 20 years old
  • Patients who have received a sufficient explanation, have sufficient understanding, and have given their free written consent.
  • Patients who have passed 2 years or more since their first total hip arthroplasty

Exclusion Criteria1

  • \. Patients who are judged to be unsuitable as research subjects by the research physician

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Interventions

DEVICEpolyethylene

No intervention as this is an observational study


Locations(2)

Mayo Clinic

Rochester, Minnesota, United States

Osaka Metropolitan University

Osaka, Japan

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NCT06432543


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