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.
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
- Conditions the study is for
- Wear of Articular Bearing Surface of Prosthetic Joint, Hip Arthropathy
- 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
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Holly A Roher, 507-266-0835, roher.holly@mayo.edu
Nicholas A Bedard, MD
Japan1 site, 1 recruiting
- Recruiting
Osaka Metropolitan University
Osaka, 5458585
Kiyoko Kato, MD
Yukihide Minoda
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 group | Role | What they receive |
|---|---|---|
| polyethylene containing Vitamin E | polyethylene 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.
Number of polyethylene wear particles
counts / g (tissue sample)
Measured: When tissue sample was collected during THA revision surgery
Equivalent circle diameter of polyethylene wear particles
equivalent circle diameter [㎛]
Measured: When tissue sample was collected during THA revision surgery
Aspect ratio of polyethylene wear particles
aspect ratio
Measured: When tissue sample was collected during THA revision surgery
Roundness of polyethylene wear particles
roundness
Measured: When tissue sample was collected during THA revision surgery
Secondary outcomes (8)
Body mass index
kg/m2
Measured: When tissue sample was collected during THA revision surgery
Hip joint flexion angle
Degrees
Measured: When tissue sample was collected during THA revision surgery
Hip joint exertion angle
Degrees
Measured: When tissue sample was collected during THA revision surgery
Hip joint adduction angle
Degrees
Measured: When tissue sample was collected during THA revision surgery
Hip joint abduction angle
Degrees
Measured: When tissue sample was collected during THA revision surgery
Hip dysfunction and Osteoarthritis Outcome. Score for Joint Replacement
0(worse)-100(best)
Measured: When tissue sample was collected during THA revision surgery
Harris Hip Score
0(worse)-100(best)
Measured: When tissue sample was collected during THA revision surgery
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.
- First posted29 May 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wear of Articular Bearing Surface of Prosthetic JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Osaka Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukihide Minoda, Osaka Metropolitan University
- Investigators
- Yukihide Minoda, MD, PhD, Principal investigator, Osaka Metropolitan University
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 17806109Hata 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 25712074Minoda 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyethylene Wear Particle Analysis of Total Hip Arthroplasty -International Multicenter Study-
- ClinicalTrials.gov ID
- NCT06432543
- Acronym / sponsor ID
- OMU 2023-132
- Keywords
- Polyethylene wear particle, Total hip arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Osaka Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic, Hospital for Special Surgery, New York, Istituto Ortopedico Rizzoli
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| polyethylene containing Vitamin E | – | Device: polyethylenepolyethylene containing Vitamin E |
| conventional polyethylene (no highly cross-linking) | – | Device: polyethyleneconventional polyethylene (no highly cross-linking) |
| conventional polyethylene (with highly cross-linking) | – | Device: polyethyleneconventional polyethylene (with highly cross-linking) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing revision hip arthroplasty within the study period
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Patients who are judged to be unsuitable as research subjects by the research physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyethyleneNo intervention as this is an observational study | Device | conventional polyethylene (no highly cross-linking), conventional polyethylene (with highly cross-linking), polyethylene containing Vitamin E |
Primary outcome
Number of polyethylene wear particles
Time frame: When tissue sample was collected during THA revision surgery
counts / g (tissue sample)
Equivalent circle diameter of polyethylene wear particles
Time frame: When tissue sample was collected during THA revision surgery
equivalent circle diameter [㎛]
Aspect ratio of polyethylene wear particles
Time frame: When tissue sample was collected during THA revision surgery
aspect ratio
Roundness of polyethylene wear particles
Time frame: When tissue sample was collected during THA revision surgery
roundness
8 secondary outcomes
Body mass index
Time frame: When tissue sample was collected during THA revision surgery
Hip joint flexion angle
Time frame: When tissue sample was collected during THA revision surgery
Hip joint exertion angle
Time frame: When tissue sample was collected during THA revision surgery
Hip joint adduction angle
Time frame: When tissue sample was collected during THA revision surgery
Hip joint abduction angle
Time frame: When tissue sample was collected during THA revision surgery
Hip dysfunction and Osteoarthritis Outcome. Score for Joint Replacement
Time frame: When tissue sample was collected during THA revision surgery
Harris Hip Score
Time frame: When tissue sample was collected during THA revision surgery
University of California at Los Angeles activity score
Time frame: When tissue sample was collected during THA revision surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Results publication: PubMed 17806109Iwakiri 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.
- Results publication: PubMed 25712074Hata 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.
- Results publication: PubMed 18360879Minoda 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.
- Individual participant dataSharing planned: No
Related trials for Wear of Articular Bearing Surface of Prosthetic Joint
Active, not recruitingObservational study
Polyethylene Wear Particle Analysis of TKA
Wear of Articular Bearing Surface of Prosthetic Joint, Total Knee Arthroplasty
Recruiting
Migration of CS vs CR Insert in TKA Using RSA
Wear of Articular Bearing Surface of Prosthetic Joint, Migration of Implant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yukihide Minoda, MD, PhD principal investigator
Osaka Metropolitan University
2 sites in 2 countries: see every site and its status.
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.