Actively Recruiting

Age: 20Years +
All Genders
NCT06432543

Polyethylene Wear Particle Analysis of THA

Led by Osaka Metropolitan University · Updated on 2025-01-20

90

Participants Needed

2

Research Sites

239 weeks

Total Duration

On this page

Sponsors

O

Osaka Metropolitan University

Lead Sponsor

M

Mayo Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Polyethylene Wear Particle Analysis of THA

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Not Yet Recruiting

2

Osaka Metropolitan University

Osaka, Japan, 5458585

Actively Recruiting

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Research Team

K

Kiyoko Kato, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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