Analysis of wear particles in hip replacement materials

Polyethylene Wear Particle Analysis of Total Hip Arthroplasty -International Multicenter Study-

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
• Enrollment: 90 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Osaka Metropolitan University (Academic / other)
• Locations: 2 sites (Rochester, Minnesota and 1 other locations)
• Trial ID: NCT06432543 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Rochester, Minnesota and 1 other locations

• Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
• Osaka Metropolitan University — Osaka, Japan (Recruiting)

Study contacts

• Principal investigator: Yukihide Minoda, MD, PhD — Osaka Metropolitan University
• Study coordinator: Kiyoko Kato, MD

Conditions Wear of Articular Bearing Surface of Prosthetic Joint; Hip Arthropathy; Polyethylene wear particle; Total hip arthroplasty