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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Other Locations
Japan
Osaka Metropolitan University
RECRUITING
Osaka
Contact Information
Primary
Kiyoko Kato, MD
Kiyoko-Kato@omu.ac.jp
81-6-6645-3851
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 90
Treatments
polyethylene containing Vitamin E
polyethylene containing Vitamin E
conventional polyethylene (no highly cross-linking)
conventional polyethylene (no highly cross-linking)
conventional polyethylene (with highly cross-linking)
conventional polyethylene (with highly cross-linking)
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, Hospital for Special Surgery, New York, Istituto Ortopedico Rizzoli
Leads: Osaka Metropolitan University

This content was sourced from clinicaltrials.gov