Polyethylene Wear Particle Analysis of TKA

The purpose of this study was to investigate whether polyethylene (Vitamin E-containing polyethylene), which has been newly introduced and widely used clinically as a biomaterial for tibial inserts in total knee arthroplasty, but whose mid- to long-term clinical results are still unknown, is more effective than conventional polyethylene. Our goal is to clarify through an international multi-center joint study using in vivo polyethylene wear particle analysis, which the investigators developed as a method to provide early feedback, as to whether polyethylene wear debris production in vivo can be reduced.

NCT Number	NCT06426641
Lead Sponsor	Osaka Metropolitan University Collaborators: Mayo Clinic, Istituto Ortopedico Rizzoli, Hospital for Special Surgery, New York
Conditions	Wear of Articular Bearing Surface of Prosthetic Joint, Total Knee Arthroplasty
Enrollment	90 participants
Start Date	2023-12-05
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-17