UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044651 |
|---|---|
| Receipt number | R000050996 |
| Scientific Title | The biomechanical assessment using MR mapping for associations ulnar head morphology with wrist articular cartilage damage: A non-randomized controlled trial |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2021/08/18 16:38:38 |
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Basic information
Public title
The biomechanical assessment using MR mapping for associations ulnar head morphology with wrist articular cartilage damage
Acronym
The wrist MRI trial
Scientific Title
The biomechanical assessment using MR mapping for associations ulnar head morphology with wrist articular cartilage damage: A non-randomized controlled trial
Scientific Title:Acronym
The wrist MRI trial
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify that differences of ulnar head morphology affect the cartilage in the wrist using MR which is no radiation exposure.
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
number of cases of each group of bone morphology, error of region of interest, intra- and inter-rater reliability, ulnar variance, length from base to top of ulnar head, morphology of lunate, ulnar coverage ratio, ratio for the most long axis of ulnar head
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
An examination of MR
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
#They have no past medical history of their wrists.
#They have no symptom in their wrists.
#They can receive examinations of MR at our hospital during a period from an approval day to December, 2023.
#Age at the time of the examination is older 20 years and less than 50 years old
Key exclusion criteria
#malignant disease
#congenital disease
#Bone destruction due to the systemic disease (e.g. rheumatoid arthritis)
#metabolic bone disease (e.g. osteoporosis)
#The person who cannot receive an examination of MR because of implanted metal in the body, claustrophobia, and the like
#The person who cannot understand the purpose and method of this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Okubo |
Organization
Department of Orthopedic Surgery, 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
Department of Orthopedic Surgery, 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, University of the Ryukyus
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
Ethics committee of university of the Ryukyus for medical and health research involving human subjects
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
| 2021 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 25 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050996
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
