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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019229
Receipt No. R000022221
Scientific Title Surgical treatment of anterior spinal fusion in patients with adolescent idiopathic scoliosis
Date of disclosure of the study information 2015/10/04
Last modified on 2015/10/05

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Basic information
Public title Surgical treatment of anterior spinal fusion in patients with adolescent idiopathic scoliosis
Acronym Surgical treatment of anterior spinal fusion in patients with adolescent idiopathic scoliosis
Scientific Title Surgical treatment of anterior spinal fusion in patients with adolescent idiopathic scoliosis
Scientific Title:Acronym Surgical treatment of anterior spinal fusion in patients with adolescent idiopathic scoliosis
Region
Japan

Condition
Condition adolescent idiopathic scoliosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Anterior spinal fusion with instrumentation is used for the treatment of thoracolumbar and lumbar (TL/L) scoliosis. This long-term, retrospective, hospital-based cohort study aimed to determine anterior dual rod instrumentation outcomes in a consecutive series of patients with TL/L adolescent idiopathic scoliosis (AIS) managed by a single surgeon at a single institution.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Radiographic measurements(Pre,Post,final follow-up)
Key secondary outcomes Outcome measures included patient demographics,pulmonary function, and Scoliosis Research Society outcome instrument (SRS-30) scores.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 anterior spinal fusion
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
10 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria adolescent idiopathic scoliosis
Key exclusion criteria 1.trauma
2.degenerative desease
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Sudo
Organization Hokkaido University
Division name Graduate school of medicine
Zip code
Address N15W7 ,Sapporo ,Japan
TEL 011-706-5934
Email hidekisudo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Sudo
Organization Hokkaido University
Division name Graduate school of medicine
Zip code
Address N15W7 ,Sapporo ,Japan
TEL 011-706-5934
Homepage URL
Email hidekisudo@yahoo.co.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
Organization
Division
Category of Funding Organization
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
2015 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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

Management information
Registered date
2015 Year 10 Month 04 Day
Last modified on
2015 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022221

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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