Polyethylene Wear Particle Analysis of THA

NCT ID: NCT06432543

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2028-12-31

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.

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]).

Conditions

Wear of Articular Bearing Surface of Prosthetic Joint; Hip Arthropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

polyethylene containing Vitamin E

polyethylene containing Vitamin E

polyethylene

Intervention Type: DEVICE

No intervention as this is an observational study

conventional polyethylene (no highly cross-linking)

conventional polyethylene (no highly cross-linking)

polyethylene

Intervention Type: DEVICE

No intervention as this is an observational study

conventional polyethylene (with highly cross-linking)

conventional polyethylene (with highly cross-linking)

polyethylene

Intervention Type: DEVICE

No intervention as this is an observational study

Interventions

polyethylene

No intervention as this is an observational study

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role: collaborator

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: collaborator

Osaka Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Yukihide Minoda

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yukihide Minoda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Osaka Metropolitan University

Locations

Mayo Clinic

Rochester, Minnesota, United States

Site Status: NOT_YET_RECRUITING

Osaka Metropolitan University

Osaka, , Japan

Site Status: RECRUITING

Countries

United States; Japan

Central Contacts

Kiyoko Kato, MD

Role: CONTACT

Kiyoko-Kato@omu.ac.jp

81-6-6645-3851

Facility Contacts

Holly A Roher

Role: primary

roher.holly@mayo.edu

507-266-0835

Kiyoko Kato, MD

Role: primary

References

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.

Reference Type: RESULT

PMID: 17806109 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25712074 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18360879 (View on PubMed)

Other Identifiers

OMU 2023-132

Identifier Type: -

Identifier Source: org_study_id