Polyethylene Wear Particle Analysis of THA

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorOsaka Metropolitan University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • polyethylene

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Osaka Metropolitan University

Lead sponsor

Mayo Clinic

Collaborator

Hospital for Special Surgery, New York

Collaborator

Istituto Ortopedico Rizzoli

Collaborator