Polyethylene Wear Particle Analysis of THA

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.

NCT Number	NCT06432543
Lead Sponsor	Osaka Metropolitan University Collaborators: Mayo Clinic, Hospital for Special Surgery, New York, Istituto Ortopedico Rizzoli
Conditions	Wear of Articular Bearing Surface of Prosthetic Joint, Hip Arthropathy
Enrollment	90 participants
Start Date	2024-06-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-20