UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028710 |
|---|---|
| Receipt number | R000032858 |
| Scientific Title | The research of QOL in patients with cervical malalignment and cervical spondylotic myelopathy using questionnaire incorporating patients |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2023/08/22 20:47:29 |
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Basic information
Public title
The research of QOL in patients with cervical malalignment and cervical spondylotic myelopathy using questionnaire incorporating patients
Acronym
QOL in patients with The research of QOL in patients with cervical disease
Scientific Title
The research of QOL in patients with cervical malalignment and cervical spondylotic myelopathy using questionnaire incorporating patients
Scientific Title:Acronym
QOL in patients with The research of QOL in patients with cervical disease
Region
| Japan |
Condition
Condition
Cervical malalignment and cervical spondylotic myelopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate outcome of conservative or surgical treatment using questionnaire incorporating patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
NDI
JOA score
History of sports activity
History of occupation
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with cervical malalignment or cervical spondylotic myelopathy who visit our hospital
Key exclusion criteria
The case which consent was not obtained from the patients or their family
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Oe |
Organization
Hamamatsu University School of Medicine
Division name
Geriatric Musculoskeletal Health
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatu city, Shizuoka, Japan
TEL
053-435-2299
mecersior@gmail.com
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Oe |
Organization
Hamamatsu university School of Medicine
Division name
Division of Musculoskeletal Health
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatu city, Shizuoka, Japan
TEL
053-435-2299
Homepage URL
mecersior@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine, Division of Mucsuloskeletal Health
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine, Division of Mucsuloskeletal Health
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
Department of Institutional Review Board, Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi ward, Hamamatsu city , Shizuoka
Tel
0534352299
mecersior@gmail.com
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
浜松医科大学付属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | 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
Under evaluation
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2017 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032858
