Polyethylene Wear Particle Analysis of THA

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Arthropathy; Wear of Articular Bearing Surface of Prosthetic Joint
• Intervention / Treatment: Device: polyethylene

Detailed Description

Research method In this study, the investigators conducted the following steps to determine the in vivo wear particles (number, size, and morphology) of conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose mid- to long-term results have not yet been clarified. Clarifying the difference.

Target of this research In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.

First total joint replacement

• 30 patients using polyethylene containing Vitamin E
• 30 patients using conventional polyethylene (no high cross-linking)
• 30 patients using conventional polyethylene (with high cross-linking)

Accumulation of periarticular tissue In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.

The test will be conducted after obtaining approval from the ethics committee at each facility and obtaining informed consent. The pericapsular tissue, which is removed during surgery and usually discarded, is obtained and fixed in formalin fixative. The tissue will be transported to the Department of Orthopedic Surgery, Osaka Public University Graduate School of Medicine for analysis. International transportation of tissues requires outsourcing to specialized companies with experience in transporting tissues from overseas.

Isolation of polyethylene wear debris The collected tissue around the joint capsule is immersed in 5Mol sodium hydroxide at 65°C for 1 hour to decompose the protein. Make a sucrose layer (5, 10, 20%) in a 14ml tube (14PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the dissolved solution, and place in an ultracentrifuge (CP100a, P28S1014 rotor, Hitachi Koki). Ultracentrifuge at 28,000 rpm [103,7009g] for 3 hours at 4°C. Prepare an isopropanol layer (0.90 and 0.96 g/mL) in a 40 ml tube (40PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the upper layer of sucrose layer, and centrifuge at 28,000 rpm (103,7009 g) and perform ultracentrifugation at 4°C for 1 hour. The isopropanol interlayer is collected to isolate polyethylene wear debris.

Analysis of polyethylene wear debris The isopropanol interlayer is filtered through a 0.1 μm polycarbonate filter (VCTP 013-00, Millipore Corporation, Bedford, MA). Dry the polycarbonate filter, fix it on an aluminum pedestal (M4, Nisshin EM Co, Ltd, Tokyo, Japan), and apply platinum coating (E-1030 ion sputter, Hitachi Science Systems Ltd, Tokyo, Japan). Observe the polyethylene wear particles on the polycarbonate filter using a scanning electron microscope (S4700SI, Hitachi Ltd, Tokyo, Japan), and analyze the following items using an image analyzer (Mac Scope, Mitani Co, Tokyo, Japan).

• Number of polyethylene wear particles (number per 1g of tissue)
• Size (Equivalent circle diameter [μm])
• Shape (aspect ratio, roundness)

Comparison of iv vivo polyethylene wear powder morphology depending on polyethylene material The number, size, and form of polyethylene wear debris will be compared between conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose medium- to long-term results have not yet been clarified. The investigators also investigated factors that affect polyethylene wear in vivo (age, height, weight, period from initial surgery to revision surgery, hip joint range of motion, hip prosthesis clinical score [Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement [HOOS Jr], Harris Hip Score, University of California Los Angeles [UCLA] activity score]).

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Kiyoko Kato, MD; Phone Number: 81-6-6645-3851; Email: Kiyoko-Kato@omu.ac.jp

Study Locations

• Japan
  • Osaka, Japan, 5458585
    • Recruiting
    • Osaka Metropolitan University
    • Contact: Kiyoko Kato, MD
    • Principal Investigator: Yukihide Minoda
• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
      • Mayo Clinic
      • Contact: Holly A Roher; Phone Number: 507-266-0835; Email: roher.holly@mayo.edu
      • Principal Investigator: Nicholas A Bedard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing revision hip arthroplasty within the study period

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
polyethylene containing Vitamin E	Device: polyethylene; No intervention as this is an observational study
conventional polyethylene (no highly cross-linking)	Device: polyethylene; No intervention as this is an observational study
conventional polyethylene (with highly cross-linking)	Device: polyethylene; No intervention as this is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	kg/m2	When tissue sample was collected during THA revision surgery
Hip joint flexion angle	Degrees	When tissue sample was collected during THA revision surgery
Hip joint exertion angle	Degrees	When tissue sample was collected during THA revision surgery
Hip joint adduction angle	Degrees	When tissue sample was collected during THA revision surgery
Hip joint abduction angle	Degrees	When tissue sample was collected during THA revision surgery
Hip dysfunction and Osteoarthritis Outcome. Score for Joint Replacement	0(worse)-100(best)	When tissue sample was collected during THA revision surgery
Harris Hip Score	0(worse)-100(best)	When tissue sample was collected during THA revision surgery
University of California at Los Angeles activity score	１(worse)-10(best)	When tissue sample was collected during THA revision surgery

Collaborators and Investigators

• Sponsor: Osaka Metropolitan University
• Collaborators: Mayo Clinic; Istituto Ortopedico Rizzoli; Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Yukihide Minoda, MD, PhD, Osaka Metropolitan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Total hip arthroplasty; Polyethylene wear particle
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: OMU 2023-132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes