UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040741 |
|---|---|
| Receipt number | R000046515 |
| Scientific Title | Prospective study of perioperative management to prevent complications after cervical spine operation |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/12/14 13:26:09 |
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Basic information
Public title
Prospective study of perioperative management to prevent complications after cervical spine operation
Acronym
Prospective study of perioperative management to prevent complications after cervical spine operation
Scientific Title
Prospective study of perioperative management to prevent complications after cervical spine operation
Scientific Title:Acronym
Prospective study of perioperative management to prevent complications after cervical spine operation
Region
| Japan |
Condition
Condition
Cervical myelopathy
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of electrophysiological study to detect postoperative subclinical C5 palsy in patients with
cervical myelopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Erb's point stimulated CMAPs (compound muscle action potential) amplitude , isometric strength, and activation in surface EMG of deltoid and biceps brachii
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with cervical myelopathy without paralysis of deltoid and biceps brachii before operation.
Key exclusion criteria
Patients with shoulder pain with rotator cuff tear or trauma history. Patients with severe systematic disease of heart, brain, neuromuscular disease, or dementia.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Miura |
Organization
Hirosaki University, graduate school of Medicine
Division name
Dept. of Rehabilitation Medicine
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, AOMORI
TEL
0172-33-5111
miurak0993@aol.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Tsuda |
Organization
Hirosaki University, Graduate School of Medicine
Division name
Dept. of Rehabilitation Medicine
Zip code
036-8562
Address
5 Saifu-cho, Hirosaki, AOMORI
TEL
0172-33-5111
Homepage URL
eiichi@hirosaki-u.ac.jp
Sponsor or person
Institute
Dept of Rehabilitation Medicine,Hirosaki University, Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
NA
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
Hirosaki University, Graduate School of Medicine
Address
5 Zaifu-cho, Hirosaki, AOMORI
Tel
0172-33-5111
rinri@hirosaki-u.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
| 2020 | Year | 06 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046515
| Research Plan | |
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| 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 |
