UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033500 |
|---|---|
| Receipt number | R000038104 |
| Scientific Title | An investigation of the efficacy of surgical treatment in patients with cervical myelopathy |
| Date of disclosure of the study information | 2018/07/25 |
| Last modified on | 2023/08/01 23:20:47 |
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Basic information
Public title
An investigation of the efficacy of surgical treatment in patients with cervical myelopathy
Acronym
An investigation of the efficacy of surgical treatment in patients with cervical myelopathy
Scientific Title
An investigation of the efficacy of surgical treatment in patients with cervical myelopathy
Scientific Title:Acronym
An investigation of the efficacy of surgical treatment in patients with cervical myelopathy
Region
| Japan |
Condition
Condition
cervical myelopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the efficacy of surgical treatment for patients with cervical myelopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Primary outcomes were the clinical evaluation and the image evaluation. We performed these assessments preoperatively and at 3, 6, 12, 18, and 24 months postoperatively.
Key secondary outcomes
1) the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) survey: preoperatively and at 3, 6, 12, 18, and 24 months postoperatively
2)the 36-Item Short Form Health Survey (SF-36): preoperatively and at 3, 6, 12, 18, and 24 months postoperatively
3)Pain Vision PS-2100 (Nipro, Osaka, Japan) the current perception threshold (CPT): preoperatively and at 3, 6, 12, 18, and 24 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
| 20 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
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
150
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Inoue |
Organization
The Jikei University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
105-8461
Address
3-25-8 Nishishinnbashi, Minato-ku, Tokyo, 105-8461, Japan
TEL
03-3433-1111
inoue@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Inoue |
Organization
The Jikei University Katsushika Medical Center
Division name
Department of Orthopaedic Surgery
Zip code
125-8506
Address
6-41-2 Aoto, Katsushika-ku, Tokyo, 125-8506, Japan
TEL
03-3603-2111
Homepage URL
inoue@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
The Jikei University School of Medicine
Address
3-25-8 Nishishinnbashi, Minato-ku, Tokyo, 105-8461, Japan
Tel
03-3433-1111
inoue@jikei.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
| 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
125
Results
Observational study
Results date posted
| 2022 | Year | 02 | Month | 02 | Day |
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
Open public recruiting
Date of protocol fixation
| 2007 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2007 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2007 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038104
| 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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