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Wear of Articular Bearing Surface of Prosthetic JointNCT06432543

Polyethylene Wear Particle Analysis of THA

An observational study of Wear of Articular Bearing Surface of Prosthetic Joint and Hip Arthropathy, run by Osaka Metropolitan University at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
polyethylene
Type of treatment
Medical device
How many people
90 participants
Where
2 sitesin 2 countries
Study dates
1 Jun 2024to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing revision hip arthroplasty within the study period

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

2 sites in 2 countries

United States1 site, 1 recruiting
  • Mayo Clinic

    Rochester, Minnesota, 55905

    Holly A Roher, 507-266-0835, roher.holly@mayo.edu

    Nicholas A Bedard, MD

    Not yet recruiting

Other trials in United States

Japan1 site, 1 recruiting
  • Osaka Metropolitan University

    Osaka, 5458585

    Kiyoko Kato, MD

    Yukihide Minoda

    Recruiting

Other trials in Japan

About this study

Official title: 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.

Read the 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]).

Being tested
polyethylene
Keywords
Polyethylene wear particle, Total hip arthroplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • polyethyleneDevice

    No intervention as this is an observational study

Study groups in NCT06432543
Study groupRoleWhat they receive
polyethylene containing Vitamin Epolyethylene containing Vitamin E
Receives: Device: polyethylene
conventional polyethylene (no highly cross-linking)conventional polyethylene (no highly cross-linking)
Receives: Device: polyethylene
conventional polyethylene (with highly cross-linking)conventional polyethylene (with highly cross-linking)
Receives: Device: polyethylene

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of polyethylene wear particles

    counts / g (tissue sample)

    Measured: When tissue sample was collected during THA revision surgery

  2. Equivalent circle diameter of polyethylene wear particles

    equivalent circle diameter [㎛]

    Measured: When tissue sample was collected during THA revision surgery

  3. Aspect ratio of polyethylene wear particles

    aspect ratio

    Measured: When tissue sample was collected during THA revision surgery

  4. Roundness of polyethylene wear particles

    roundness

    Measured: When tissue sample was collected during THA revision surgery

Secondary outcomes (8)
  1. Body mass index

    kg/m2

    Measured: When tissue sample was collected during THA revision surgery

  2. Hip joint flexion angle

    Degrees

    Measured: When tissue sample was collected during THA revision surgery

  3. Hip joint exertion angle

    Degrees

    Measured: When tissue sample was collected during THA revision surgery

  4. Hip joint adduction angle

    Degrees

    Measured: When tissue sample was collected during THA revision surgery

  5. Hip joint abduction angle

    Degrees

    Measured: When tissue sample was collected during THA revision surgery

  6. Hip dysfunction and Osteoarthritis Outcome. Score for Joint Replacement

    0(worse)-100(best)

    Measured: When tissue sample was collected during THA revision surgery

  7. Harris Hip Score

    0(worse)-100(best)

    Measured: When tissue sample was collected during THA revision surgery

  8. University of California at Los Angeles activity score

    1(worse)-10(best)

    Measured: When tissue sample was collected during THA revision surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start1 Jun 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06432543
Sponsor's protocol ID
OMU 2023-132
Status last verified
Jan 2025
First submitted
16 May 2024
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 17806109
  • 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.

    PubMed 25712074
  • 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.

    PubMed 18360879

Questions about this trial

What is this clinical trial studying?

An observational study of Wear of Articular Bearing Surface of Prosthetic Joint and Hip Arthropathy, run by Osaka Metropolitan University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kiyoko Kato, MD (81-6-6645-3851, Kiyoko-Kato@omu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of polyethylene wear particles (time frame: When tissue sample was collected during THA revision surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06432543, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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