Actively Recruiting

Age: 20Years +
All Genders
ID06432543

Polyethylene Wear Particle Analysis of Total Hip Arthroplasty International Multicenter Study

Led by Osaka Metropolitan University · Updated on 2025-01-20

90

Participants Needed

2

Research Sites

239 weeks

Total Duration

On this page

Sponsors

O

Osaka Metropolitan University

Lead Sponsor

M

Mayo Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the wear of polyethylene materials used in total hip arthroplasty (THA), focusing on a new vitamin E-containing polyethylene compared to conventional types. This international multicenter study aims to determine whether the vitamin E polyethylene produces fewer wear particles in the body, which could improve long-term outcomes, using a specialized in vivo wear debris analysis method developed by the investigators. The study involves collecting tissue samples from patients undergoing routine revision hip arthroplasty. Three groups of 30 patients each will be compared: those with vitamin E-containing polyethylene, conventional polyethylene without high cross-linking, and conventional polyethylene with high cross-linking. Tissue removed during surgery is processed to isolate polyethylene wear debris, which is then analyzed under a scanning electron microscope to measure the number, size, and shape of the particles. Participants will have clinical data collected, including age, height, weight, time since initial surgery, hip range of motion, and clinical scores such as HOOS Jr, Harris Hip Score, and UCLA activity score. The study measures the polyethylene wear particles' characteristics during revision surgery to compare the materials. This observational study monitors safety and outcomes without additional interventions.

CONDITIONS

Official Title

Polyethylene Wear Particle Analysis of THA

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients who are judged to be unsuitable as research subjects by the research physician

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Not Yet Recruiting

2

Osaka Metropolitan University

Osaka, Japan, 5458585

Actively Recruiting

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Research Team

K

Kiyoko Kato, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

Frequently Asked Questions

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Published Research Related To This Trial

Characteristics of Hylamer polyethylene particles isolated from peri-prosthetic tissues of failed cemented total hip arthroplasties.

Kentaro Iwakiri, Hiroyoshi Iwaki, Akio Kobayashi...

https://pubmed.ncbi.nlm.nih.gov/17806109

In vivo wear particles of remelted highly crosslinked polyethylene after total hip arthroplasty: report of four cases.

Kanako Hata, Yukihide Minoda, Mitsuhiko Ikebuchi...

https://pubmed.ncbi.nlm.nih.gov/25712074