UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026953 |
|---|---|
| Receipt number | R000030902 |
| Scientific Title | Evaluation of the clinical usefulness of CT in a standing or sitting position for musculoskeletal and spine disorders |
| Date of disclosure of the study information | 2017/04/30 |
| Last modified on | 2023/07/18 15:27:43 |
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Basic information
Public title
Evaluation of the clinical usefulness of CT in a standing or sitting position for musculoskeletal and spine disorders
Acronym
CT in a standing or sitting position for musculoskeletal and spine disorders
Scientific Title
Evaluation of the clinical usefulness of CT in a standing or sitting position for musculoskeletal and spine disorders
Scientific Title:Acronym
CT in a standing or sitting position for musculoskeletal and spine disorders
Region
| Japan |
Condition
Condition
Musculoskeletal and spine disorders
Classification by specialty
| Orthopedics | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate morphological features in patients with musculoskeletal or spine disorders under load condition by using horizontal CT.
To clarify the 4-dimensional motion and motor dysfunction of the spine or extremity in patients as compared with normal volunteers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological parameters on images
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Horizontal CT in a standing and sitting positions
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with motor dysfunction due to spinal trauma, limb trauma, or any diseases. (Age equal to or more than 16 years)
2. Healthy volunteers without history of spine disorders or musculoskeletal disease. (Age equal to or more than 20 years)
Key exclusion criteria
1. Known or possible pregnancy
2. Subjects who are not able to undergo CT in a standing or sitting position
3. Subjects who do not provide written informed consent
4. Any history of spinal trauma, limb trauma, or operation in healthy volunteer
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Jinzaki |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1977(+81-3-3353-1977)
jinzaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Nagura |
Organization
Keio University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3812(+81-3-5363-3812)
Homepage URL
nagura@z8.keio.jp
Sponsor or person
Institute
Department of Radiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Canon Medical Systems Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Medicine, Keio University, Ethical Commitee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel
03-5363-3503(+81-3-5363-3503)
med-rinri-jimu@adst.keio.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
| 2017 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
243
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030902
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
