UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041090 |
|---|---|
| Receipt number | R000046928 |
| Scientific Title | Comparative study for the results of open-door laminoplasty using the plate alone and the plate with spacer |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2022/02/21 20:53:55 |
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Basic information
Public title
Comparative study for the results of open-door laminoplasty using the plate alone and the plate with spacer
Acronym
Comparative study for the results of laminoplasty using the plate alone and the plate with spacer
Scientific Title
Comparative study for the results of open-door laminoplasty using the plate alone and the plate with spacer
Scientific Title:Acronym
Comparative study for the results of laminoplasty using the plate alone and the plate with spacer
Region
| Japan |
Condition
Condition
cervical spondylotic myelopathy
Classification by specialty
| Orthopedics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the clinical results of laminoplasty using a plate alone and that using a plate with spacer for cervical spondylotic myelopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical outcome measured by JOA, JOACMEQ and VAS
Key secondary outcomes
Complications or any harmful effects, radiological evaluations, surgical costs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
laminoplasty using the plate alone
Interventions/Control_2
laminoplasty using the plate with spacer
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Myelopathy or myeloradiculopathy caused by cervical spondylosis or OPLL
Key exclusion criteria
The patients with malignant tumor or purulent spondylitis
The patients with prior surgery history for cervical myelopathy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka City Juso Hospital
Division name
Department of Orthopedic surgery
Zip code
5320034
Address
2-12-27, Nonakakita, Yodogawa-ku, Osaka
TEL
0661508000
kh_ocg@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka City Juso Hospital
Division name
Department of Orthopedic surgery
Zip code
532-0034
Address
2-12-27, Nonakakita, Yodogawa-ku, Osaka
TEL
0661508000
Homepage URL
kh_ocg@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopedic surgery, Osaka City Juso Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Osaka City Juso Hospital
Address
2-12-27, Nonakakita, Yodogawa-ku, Osaka
Tel
0661508000
close to public
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 | 08 | 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
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
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046928
| 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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| Registered date | File name |
