UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002787 |
|---|---|
| Receipt number | R000003388 |
| Scientific Title | Multiple center study for establishing treatment of spinal scoliosis |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2023/06/07 19:56:07 |
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Basic information
Public title
Multiple center study for establishing treatment of spinal scoliosis
Acronym
Spinal scoliosis multiple center study
Scientific Title
Multiple center study for establishing treatment of spinal scoliosis
Scientific Title:Acronym
Spinal scoliosis multiple center study
Region
| Japan |
Condition
Condition
Spinal scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish data base among multiple hospital to share the data of spinal scoliosis. Evaluate efficacies of conventional treatment, and establish treatments for spinal scoliosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical course, pulmonaly function, radiographical findings(Xray, MRI, CT), questionnaire(SRS30, SF-36)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Cobb angle of 20 degrees or more
2.Follow uped for 1year or more
3.Allowance for paticipation could be obtained
4. Idiopathic scoliosis, congenital scoliosis, syndromic scoliosis, neuromuscular scoliosis
5.All generation
Key exclusion criteria
1.Cobb angle of less than 20 degrees
2.Less than 1 year follow up
3.Allowance for paticipation could no be obtained
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Watanabe |
Organization
Keio Univ, School of Medicine, Tokyo, Japan
Division name
Department of Orthopedic Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo, #160-8582, Japan
TEL
03-3353-1211
watakota@gmail.com
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Watanabe |
Organization
Keio University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku
TEL
03-5363-3812
Homepage URL
watakota@gmail.com
Sponsor or person
Institute
Department of Orthopedic Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meijo Hop.
Kobe Medical Center
Seirei Sakura Citizen Hosp.
Jyuntendo Univ. Hosp.
Murayama medical center
Dokkyo Univ. Koshigaya Hosp.
Keio Univ. Faculty of Science and Engineering
Fukuoka Children Hosp.
Nigata Univ. Hosp
Kanazawa Univ. Hosp.
Tokyo Univ. Hosp.
Kagoshima Univ. Hosp.
Jichi Medical Univ. Hops.
Iwate Medical Univ. Hosp.
St Marianna Univ. Hosp.
Kobe Univ. Hosp.
Saga Univ. Hosp.
Nara Medical Univ. Hosp.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, IRB
Address
35 Shinanomachi, Shinjyuku-ku
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2009 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2031 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 05 | Month | 31 | Day |
Other
Other related information
The purpose of this study is to share medical information (treatment progress, image data, surgical results, questionnaire survey results) of scoliosis cases at multiple centers and establish an appropriate treatment method.
Management information
Registered date
| 2009 | Year | 11 | Month | 20 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003388
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
