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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033500
Receipt No. R000038104
Scientific Title An investigation of neurological recovery after cervical laminoplasty for cervical myelopathy.
Date of disclosure of the study information 2018/07/25
Last modified on 2018/07/24

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Basic information
Public title An investigation of neurological recovery after cervical laminoplasty for cervical myelopathy.
Acronym An investigation of neurological recovery after cervical laminoplasty for cervical myelopathy.
Scientific Title An investigation of neurological recovery after cervical laminoplasty for cervical myelopathy.
Scientific Title:Acronym An investigation of neurological recovery after cervical laminoplasty for cervical myelopathy.
Region
Japan

Condition
Condition cervical myelopathy
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate of neurological recovery after cervical laminoplasty for cervical myelopathy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes An investigation of clinical evaluation and image evaluation.
preoperatively and at 7days postoperatively, and 1, 3, 6, 12 months postoperatively
Key secondary outcomes 1) the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) survey: preoperatively and at 3, 6, and 12 months postoperatively
2)the 36-Item Short Form Health Survey (SF-36): preoperatively and at 3, 6, and 12 months postoperatively
3)Pain Vision PS-2100 (Nipro, Osaka, Japan) the current perception threshold (CPT): preoperatively and at 3, 6, and 12 months postoperatively

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria cervical myelopathy
Key exclusion criteria The exclusion criteria were as follows: (1) history of cervical surgery;
(2) history of cerebral palsy;
(3) thoracic spondylotic myelopathy;
(4) lumber disc herniation or lumber canal stenosis;
(5) cervical radiculopathy;
(6) rheumatoid arthritis;
(7) destructive spondyloarthritis due to hemodialysis;
(8) spinal cord tumor;
(9) spinal cord injuries;
(10) spinal fusion surgery.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keishi Marumo
Organization The Jikei University School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 3-25-8 Nishishinnbashi, Minato-ku, Tokyo, 105-8461, Japan
TEL 03-3433-1111
Email marumo@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Inoue
Organization The Jikei University Katsushika Medical Center
Division name Department of Orthopaedic Surgery
Zip code
Address 6-41-2 Aoto, Katsushika-ku, Tokyo, 125-8506, Japan
TEL 03-3603-2111
Homepage URL
Email inoue@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University School of Medicine
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
Email

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
2018 Year 07 Month 25 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
Observational study
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 No longer recruiting
Date of protocol fixation
2007 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 07 Month 24 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038104

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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