Polyethylene Wear Particle Analysis of THA

NCT06432543 | Recruiting FDA Device

• 1 other identifier: OMU 2023-132
• Study Type: observational
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Wear of Articular Bearing Surface of Prosthetic Joint; Hip Arthropathy

Keywords

Polyethylene wear particle; Total hip arthroplasty

Outcome Measures

Primary Outcomes (4)

• Number of polyethylene wear particles

  counts / g (tissue sample)

  When tissue sample was collected during THA revision surgery

• Equivalent circle diameter of polyethylene wear particles

  equivalent circle diameter \[㎛\]

  When tissue sample was collected during THA revision surgery

• Aspect ratio of polyethylene wear particles

  aspect ratio

  When tissue sample was collected during THA revision surgery

• Roundness of polyethylene wear particles

  roundness

  When tissue sample was collected during THA revision surgery

Secondary Outcomes (8)

• Body mass index

  When tissue sample was collected during THA revision surgery

• Hip joint flexion angle

  When tissue sample was collected during THA revision surgery

• Hip joint exertion angle

  When tissue sample was collected during THA revision surgery

• Hip joint adduction angle

  When tissue sample was collected during THA revision surgery

• Hip joint abduction angle

  When tissue sample was collected during THA revision surgery

Study Arms (3)

polyethylene containing Vitamin E

polyethylene containing Vitamin E

Device: polyethylene

conventional polyethylene (no highly cross-linking)

conventional polyethylene (no highly cross-linking)

Device: polyethylene

conventional polyethylene (with highly cross-linking)

conventional polyethylene (with highly cross-linking)

Device: polyethylene

Interventions

polyethylene DEVICE

No intervention as this is an observational study

conventional polyethylene (no highly cross-linking); conventional polyethylene (with highly cross-linking); polyethylene containing Vitamin E

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing revision hip arthroplasty within the study period

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Osaka Metropolitan University: lead
• Mayo Clinic: collaborator
• Hospital for Special Surgery, New York: collaborator
• Istituto Ortopedico Rizzoli: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Osaka Metropolitan University

Osaka, 5458585, Japan

RECRUITING

Related Publications (3)

• Iwakiri K, Iwaki H, Kobayashi A, Minoda Y, Kagiyama H, Kadoya Y, Takaoka K. Characteristics of Hylamer polyethylene particles isolated from peri-prosthetic tissues of failed cemented total hip arthroplasties. J Biomed Mater Res B Appl Biomater. 2008 Apr;85(1):125-9. doi: 10.1002/jbm.b.30924.

  PMID: 17806109 RESULT

• Hata K, Minoda Y, Ikebuchi M, Mizokawa S, Ohta Y, Miyazaki N, Miyake Y, Nakamura H. In vivo wear particles of remelted highly crosslinked polyethylene after total hip arthroplasty: report of four cases. J Mater Sci Mater Med. 2015 Mar;26(3):133. doi: 10.1007/s10856-015-5472-9. Epub 2015 Feb 25.

  PMID: 25712074 RESULT

• Minoda Y, Kobayashi A, Sakawa A, Aihara M, Tada K, Sugama R, Iwakiri K, Ohashi H, Takaoka K. Wear particle analysis of highly crosslinked polyethylene isolated from a failed total hip arthroplasty. J Biomed Mater Res B Appl Biomater. 2008 Aug;86(2):501-5. doi: 10.1002/jbm.b.31048.

  PMID: 18360879 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

The pericapsular tissue, which is removed during surgery

Study Officials

• Yukihide Minoda, MD, PhD

  Osaka Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiyoko Kato, MD

CONTACT

81-6-6645-3851; Kiyoko-Kato@omu.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 29, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); JP (1)