Polyethylene Wear Particle Analysis of THA

Recruiting now

Conditions studied: Wear of Articular Bearing Surface of Prosthetic Joint, Hip Arthropathy

In brief

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.

Key facts

Study ID

NCT06432543

Run by

Osaka Metropolitan University

People needed

90

Starts

2024-06-01

Expected to finish

2028-12-31

Last updated by the study team

2025-01-20

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Osaka Metropolitan University — Osaka, Japan (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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