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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002787
Receipt No. 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 2009/11/20

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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
Middle name
Last name Morio Matsumoto
Organization Keio Univ, School of Medicine, Tokyo, Japan
Division name Department of Orthopedic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, #160-8582, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Department of Orthopedic Surgery
Zip code
Address
TEL 03-5363-3812
Homepage URL
Email

Sponsor
Institute Department of Orthopedic Surgery, Keio University School of Medicine
Institute
Department

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.
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
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
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2014 Year 05 Month 01 Day
Date of closure to data entry
2014 Year 05 Month 01 Day
Date trial data considered complete
2014 Year 05 Month 01 Day
Date analysis concluded
2014 Year 05 Month 01 Day

Other
Other related information Establishment of protocol for the study will be performed on 28th Nov. The study will start from that date.

Management information
Registered date
2009 Year 11 Month 20 Day
Last modified on
2009 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.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


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