Polyethylene Wear Particle Analysis of THA
Condition(s) studied
Investigational drug(s) / intervention(s)
polyethylene: No intervention as this is an observational study
Study summary
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
Primary outcome measure(s)
- Number of polyethylene wear particles — When tissue sample was collected during THA revision surgery
counts / g (tissue sample) - Equivalent circle diameter of polyethylene wear particles — When tissue sample was collected during THA revision surgery
equivalent circle diameter \[㎛\] - Aspect ratio of polyethylene wear particles — When tissue sample was collected during THA revision surgery
aspect ratio - Roundness of polyethylene wear particles — When tissue sample was collected during THA revision surgery
roundness
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | Not Yet Recruiting |
| Osaka Metropolitan University | Osaka | Japan | Recruiting |
More Osaka Metropolitan University trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06432543 on ClinicalTrials.gov ↗ ← All trials in Japan