UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026186 |
|---|---|
| Receipt number | R000027644 |
| Scientific Title | Prospective RCT study of comparison the cervical laminoplasty and cervical laminoplasty with C3 laminectomy for cervical spondylosis myelopathy |
| Date of disclosure of the study information | 2017/02/17 |
| Last modified on | 2017/02/17 09:11:09 |
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Basic information
Public title
Prospective RCT study of comparison the cervical laminoplasty and cervical laminoplasty with C3 laminectomy for cervical spondylosis myelopathy
Acronym
Prospective RCT study of cervical laminoplasty with third C3 laminectomy
Scientific Title
Prospective RCT study of comparison the cervical laminoplasty and cervical laminoplasty with C3 laminectomy for cervical spondylosis myelopathy
Scientific Title:Acronym
Prospective RCT study of cervical laminoplasty with third C3 laminectomy
Region
| Japan |
Condition
Condition
Cervical spondylotic myelopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of C3 laminectomy added in cervical laminoplasty by Hirabayashi method by comparing conventional cervical laminoplasty by Hirabayashi method for cervical spondylosis myelopathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JOA Cervical Myelopathy Evaluation Questionnaire (JOACMEQ)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
At the C3 lamina, laminectomy is performed.
Interventions/Control_2
At the C3 lamina, laminoplasty is performed.
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
The yellow race living in Japan who is diagnosed with cervical spondylosis myelopathy and who is scheduled for surgery. The surgery is cervical laminoplasty by Hirabayashi method (C3 from C6).
Key exclusion criteria
Patients who has posterior longitudinal ligament ossification, cervical spine trauma history, cervical spine surgery history, a disease which affects attitude reflex, such as Parkinson's disease.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Tanaka |
Organization
Okayama University Hospital
Division name
The department of orthopedic surgery
Zip code
Address
2-5-1 Shikata-cho, Okayama City, Okayama, Japan
TEL
086-235-7273
tanakam@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Oda |
Organization
Okayama University Hospital
Division name
The department of orthopedic surgery
Zip code
Address
2-5-1 Shikata-cho, Okayama City, Okayama, Japan
TEL
086-235-7273
Homepage URL
p0m27nbo@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | 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
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2017 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027644
| 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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