UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052382 |
|---|---|
| Receipt number | R000059796 |
| Scientific Title | Polyethylene wear particle analysis of total knee arthroplasty -international multicenter study- |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/10/20 21:25:37 |
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Basic information
Public title
Polyethylene wear particle analysis of total knee arthroplasty -international multicenter study-
Acronym
Polyethylene wear particle analysis of total knee arthroplasty -international multicenter study-
Scientific Title
Polyethylene wear particle analysis of total knee arthroplasty -international multicenter study-
Scientific Title:Acronym
Polyethylene wear particle analysis of total knee arthroplasty -international multicenter study-
Region
| Japan | North America | Europe |
Condition
Condition
Revision total knee arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate in vivo wear particles of newly introduced highly cross-linked polyethylene (HXLPE) with anti-oxidant which has not yet have long-term clinical results and to compare in vivo wear particles between HXLPE with antioxidant, HXLPE without antioxidant, and conventional polyethylene.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of polyethylene wear particles (particles/g of wet tissue sample) in the tissue sample.
Particle size, which was expressed using the equivalent circle diameter (ECD).
Particle shape, which was determined on the basis of the aspect ratio and roundness.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing revision knee arthroplasty within the study period
Key exclusion criteria
Patients who are judged to be unsuitable as subjects by the study director (sub-sponsor) physician.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yukihide |
| Middle name | |
| Last name | Minodaa |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3851
yminoda@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yukihide |
| Middle name | |
| Last name | Minoda |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3851
Homepage URL
yminoda@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Graduate School of Medicine
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3851
yminoda@omu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Mayo Clinic, USA、Hospital for Special Surgery, USA、Istituto Ortopedico Rizzoli, Italia、なにわ生野病院（大阪府）、大阪公立大学大学院医学研究科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before starting
Management information
Registered date
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059796
