Polyethylene Wear Particle Analysis of THA

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Osaka Metropolitan University
Study ID
NCT06432543
Status
Recruiting
Apply to this trial

Conditions

  • Hip Arthropathy
  • Wear of Articular Bearing Surface of Prosthetic Joint

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • polyethylene — DEVICE
    No intervention as this is an observational study

Study Details

Purpose of research The purpose of this study was to demonstrate that polyethylene (Vitamin E-containing polyethylene), a newly introduced biomaterial for tibial inserts in hip replacement surgery and widely used clinically, but whose mid- to long-term clinical results are still unknown, is superior to conventional polyethylene in vivo. The aim of this project is to conduct an international multi-center joint research study to determine whether polyethylene wear debris production can be reduced in the future, using an in vivo polyethylene wear debris analysis method that the investigators developed as a method that can provide early feedback.

Key Dates

Start date
Jun 1, 2024
Status verified
Jan 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: polyethylene containing Vitamin E
    polyethylene containing Vitamin E
  • Arm: conventional polyethylene (no highly cross-linking)
    conventional polyethylene (no highly cross-linking)
  • Arm: conventional polyethylene (with highly cross-linking)
    conventional polyethylene (with highly cross-linking)

Primary Outcome Measure

Number of polyethylene wear particles [ Time Frame: When tissue sample was collected during THA revision surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Holly A Roher
[email protected]
507-266-0835
Nicholas A Bedard, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MN

Related Studies