UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019229 |
|---|---|
| Receipt number | 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 12:38:50 |
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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
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
hidekisudo@yahoo.co.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
