Polyethylene Wear Particle Analysis of TKA
Condition(s) studied
Investigational drug(s) / intervention(s)
Polyethylene: There is no intervention
Study summary
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.
Eligibility
Primary outcome measure(s)
- Number of polyethylene wear particles — Time of revision surgery
counts / g (tissue sample) - Equivalent circle diameter of polyethylene wear particles — Time of revision surgery
Equivalent circle diameter (㎛) - Aspect ratio of polyethylene wear particles — Time of revision surgery
Aspect ratio - Roundness of polyethylene wear particles — Time of revision surgery
Roundness
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | |
| Osaka Metroplitan Univerity | Osaka | Japan |
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 NCT06426641 on ClinicalTrials.gov ↗ ← All trials in Japan