Polyethylene Wear Particle Analysis of THA

ConditionsWear of Articular Bearing Surface of Prosthetic Joint Hip Arthropathy

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

This trial does not accept healthy volunteers

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 population

Patients undergoing revision hip arthroplasty within the study period

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

polyethylene
Device
No intervention as this is an observational study

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: polyethylene containing Vitamin E1 intervention

Group B: conventional polyethylene (no highly cross-linking)1 intervention

Group C: conventional polyethylene (with highly cross-linking)1 intervention

Trial outcomes