Analysis of wear particles in hip replacement materials
Official title: Polyethylene Wear Particle Analysis of Total Hip Arthroplasty -International Multicenter Study-
Run by Osaka Metropolitan University · NCT06432543 · Data updated 2026-11-12
This study is testing whether a newer type of plastic used in hip replacements makes less wear debris than the traditional type, to see if it can help patients have better long-term results after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Osaka Metropolitan University Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | January 20, 2025 |
| Trial ID | NCT06432543 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients over 20 years old who are undergoing revision hip arthroplasty and have had their first total hip arthroplasty at least two years prior.
✕Probably not a fit
Patients who are deemed unsuitable by the research physician or those who have not undergone a prior total hip arthroplasty will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare the wear debris produced by two types of polyethylene used in hip arthroplasty: conventional polyethylene and vitamin E-containing polyethylene. The research will involve patients undergoing revision hip arthroplasty, where tissue samples will be collected and analyzed for wear particle characteristics. The study seeks to determine if the newer polyethylene material results in less wear debris compared to traditional options, potentially leading to improved long-term outcomes for patients. The analysis will be conducted at multiple international centers, including the Mayo Clinic and Osaka Metropolitan University.
Why it matters
Potential benefit: If successful, this study could lead to improved materials for hip replacements, reducing wear and prolonging the lifespan of prosthetic joints.
How similar studies have gone: Previous studies have shown varying success with similar approaches in analyzing wear debris, but this specific comparison of vitamin E-containing polyethylene is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients undergoing revision hip arthroplasty within the study period 2. Patients over 20 years old 3. Patients who have received a sufficient explanation, have sufficient understanding, and have given their free written consent. 4. Patients who have passed 2 years or more since their first total hip arthroplasty Exclusion Criteria: 1\. Patients who are judged to be unsuitable as research subjects by the research physician
Where it's running
-
Osaka Metropolitan University
Osaka, Japan Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Not yet recruiting
Study contacts
- Principal investigator: Yukihide Minoda, MD, PhD — Osaka Metropolitan University
- Study coordinator: Kiyoko Kato, MD
- Email: Kiyoko-Kato@omu.ac.jp
- Phone: 81-6-6645-3851
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.