UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040997 |
|---|---|
| Receipt number | R000044535 |
| Scientific Title | Investigation of the running of nerve branch supplying the vastus medialis muscle using nerve stimulation-A prospective observational study- |
| Date of disclosure of the study information | 2020/07/04 |
| Last modified on | 2023/07/07 09:20:40 |
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Basic information
Public title
Investigation of the running of nerve branch supplying the vastus medialis muscle using nerve stimulation-A prospective observational study-
Acronym
Investigation of the running of nerve branch supplying the vastus medialis muscle using nerve stimulation-A prospective observational study-
Scientific Title
Investigation of the running of nerve branch supplying the vastus medialis muscle using nerve stimulation-A prospective observational study-
Scientific Title:Acronym
Investigation of the running of nerve branch supplying the vastus medialis muscle using nerve stimulation-A prospective observational study-
Region
| Japan |
Condition
Condition
Diseases requiring knee surgery performed under general anesthesia
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Functional evaluation of the running of the nerve branch supplying the vastus medialis muscle, especially through the adductor myotubes or not, using a nerve stimulator
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contraction of the vastus medialis muscle with nerve stimulation at the adductor canal
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 who are ASA-PS 1-3
Patients who consented to participate in this study
Key exclusion criteria
Patients who did not give their consent
Patients who are BMI> 30
Patients who have Diabetics
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Watanabe |
Organization
Uonuma Kikan Hospital
Division name
Division of Anesthesia
Zip code
949-7302
Address
4132, Urasa, Minami-Uonuma City, Niigata
TEL
025-777-3200
deepimpact034@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Watanabe |
Organization
Uonuma Kikan Hospital
Division name
Division of Anesthesiology
Zip code
949-7302
Address
4132, Urasa, Minami-Uonuma City, Niigata
TEL
025-777-3200
Homepage URL
deepimpact034@yahoo.co.jp
Sponsor or person
Institute
Uonuma Kikan Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Uonuma Kikan Hospital
Address
4132, Urasa, Minami-Uonuma City, Niigata
Tel
025-777-3200
yaku-info@ncmi.or.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
| 2020 | Year | 07 | Month | 04 | 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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 21 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 21 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 10 | Day |
Other
Other related information
We observe the movement of the vastus medialis during nerve stimulation
Management information
Registered date
| 2020 | Year | 07 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044535
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/05/14 | 倫理_研究計画書(神経刺激).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
