UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051010 |
|---|---|
| Receipt number | R000058151 |
| Scientific Title | Qualitative evaluation of cartilage by morphology of the distal radial joint using T1rho and T2 mapping : retrospective observational study |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/05/09 00:33:26 |
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Basic information
Public title
Evaluation of cartilage by morphology of the distal radial joint using MRI
Acronym
Evaluation of cartilage by morphology of the distal radial joint using MRI
Scientific Title
Qualitative evaluation of cartilage by morphology of the distal radial joint using T1rho and T2 mapping : retrospective observational study
Scientific Title:Acronym
Qualitative evaluation of cartilage by morphology of the distal radial joint using T1rho and T2 mapping
Region
| Japan |
Condition
Condition
Distal radioulnar joint osteoarthritis
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between bone morphology of DRUJ in healthy subjects and the degree of cartilage degeneration in DRUJ using T1rho and T2 mapping
Basic objectives2
Others
Basic objectives -Others
Biological evaluation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Values of cartilages in the wrist provided by an examination of qualitative MR
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
In another clinical study conducted at our hospital, all volunteers who underwent wrist MRI examinations
Key exclusion criteria
Exclude when the individual or his/her representative requests refusal to participate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Okubo |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Department of Orthopedic Surgery
Zip code
903-0215
Address
270 Uehara, Nishihara, Okinawa, Japan
TEL
+81988951174
okubo531@u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Onaka |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Department of Orthopedic Surgery
Zip code
903-0215
Address
270 Uehara, Nishihara, Okinawa, Japan
TEL
+81988951174
Homepage URL
k208750@eve.u-ryukyu.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of the Ryukyus Ethics Review Committee
Address
270 Uehara, Nishihara, Okinawa, Japan
Tel
+81988951542
krinken@acs.u-ryukyu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 15 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For DRUJ-OA, we assess whether DRUJ bone morphology before deformation is a risk for the occurrence of the disease.
Management information
Registered date
| 2023 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058151
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
