UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020980 |
|---|---|
| Receipt number | R000024213 |
| Scientific Title | Can C5 palsy after cervical decompression be predicted by using pre-surgical cervical ultrasonography? |
| Date of disclosure of the study information | 2016/02/12 |
| Last modified on | 2018/04/16 10:59:23 |
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Basic information
Public title
Can C5 palsy after cervical decompression be predicted by using pre-surgical cervical ultrasonography?
Acronym
C5 palsy prediction by cervical ultrasonography.
Scientific Title
Can C5 palsy after cervical decompression be predicted by using pre-surgical cervical ultrasonography?
Scientific Title:Acronym
C5 palsy prediction by cervical ultrasonography.
Region
| Japan |
Condition
Condition
Patients received cervical decompression surgery
Classification by specialty
| Orthopedics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of cervical ultrasonography to predict the C5 pasty after cervical decompression surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine the diagnosis cut-off value (sensitivity and specificity) of a cross sectional area of the C5 nerve root between post-surgical C5 palsy group and non-C5 palsy group.
Key secondary outcomes
To compare the CSAs of C6 and C7 nerve roots both groups.
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
Cerivcial nerver root ultrasonography is pre-surgically performed one time for all patients who undergo cervical decompression surgery by ultrasonic technicians.
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 reviewed cervical decompression surgery. Postoperative C5 palsy was defined as occurring deltoid muscle weakness in grade 3 or less by muscle manual test (MMT) without any deterioration of myelopathy after surgery.
Key exclusion criteria
Patients with trauma case, dialysis, severe diabetes, severe renal or liver dysfunction, collagen disease, neuromuscular disease, or pre-surgical deltoid palsy.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikinobu (First name) Takeuchi (Last name) |
Organization
Aichi Medical University
Division name
Spine Center
Zip code
Address
1-1, Karimata, Yazako, Nagakute City, Aichi
TEL
0561-62-3311
take7106@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikinobu (First name) Takeuchi (Last name) |
Organization
Aichi Medical University
Division name
Spine Center
Zip code
Address
1-1, Karimata, Yazako, Nagakute City, Aichi
TEL
0561-62-3311
Homepage URL
take7106@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Nagoya Spine Group
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
Address
Tel
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
選択
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 12 | 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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 11 | Day |
Last modified on
| 2018 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024213
