UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052160 |
|---|---|
| Receipt number | R000059532 |
| Scientific Title | Proposal of the Concept of "Tractional Spinal Cord Injury" - a case series - |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/09/09 16:41:06 |
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Basic information
Public title
Proposal of the Concept of "Tractional Spinal Cord Injury" - a case series -
Acronym
Proposal of the Concept of "Tractional Spinal Cord Injury"
Scientific Title
Proposal of the Concept of "Tractional Spinal Cord Injury" - a case series -
Scientific Title:Acronym
Proposal of the Concept of "Tractional Spinal Cord Injury"
Region
| Japan |
Condition
Condition
Tractional Spinal Cord Injury, Spinal concussion, SCIWORA
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimsto present the concept and the diagnostic criteria of traction spinal cord injury.
Basic objectives2
Others
Basic objectives -Others
This study aims to present a specific image, a physical examination.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tight film terminale provocation test, MRI Shortcut sign
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We examined the patients treated in our hospital between January 2015 and December 2019 who displayed symptoms consistent with cervical spinal cord injuries post-trauma.
Key exclusion criteria
incomprehensive medical records.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | AKIRA |
| Middle name | |
| Last name | ITOI |
Organization
Juntendo University. Shizuoka Hospital
Division name
Department of Orthopaedic Surgery
Zip code
4102211
Address
Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
TEL
0559483111
aitoi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | AKIRA |
| Middle name | |
| Last name | ITOI |
Organization
Juntendo University. Shizuoka Hospital
Division name
Department of Orthopaedic Surgery
Zip code
4102211
Address
Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
TEL
0559483111
Homepage URL
aitoi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University. Shizuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Own resources
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Orthopaedic Surgery., Juntendo University. Shizuoka Hospital
Address
Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
Tel
0559483111
aitoi@juntendo.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 | 11 | 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
9
Results
Injury areas were observed with laterality in many cases. All five patients who underwent the TFT test had positive results. There are no MRI shortcut signs (-). Every patient responded positively to conservative treatment rapidly, but one reported lasting numbness.
Results date posted
| 2023 | Year | 09 | Month | 09 | Day |
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
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2023 | Year | 09 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059532
