MedTrace Logo

Polyethylene Wear Particle Analysis of TKA

NCT06426641 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-01-17

No results posted yet for this 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.

Conditions

  • Wear of Articular Bearing Surface of Prosthetic Joint
  • Total Knee Arthroplasty

Interventions

DEVICE

Polyethylene

There is no intervention

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Istituto Ortopedico Rizzoli

    collaborator OTHER

  • Hospital for Special Surgery, New York

    collaborator OTHER

  • Osaka Metropolitan University

    lead OTHER

Principal Investigators

  • Yukihide Minoda, MD, PhD · Osaka Metropolitan University

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06426641 on ClinicalTrials.gov