UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017462 |
|---|---|
| Receipt number | R000020240 |
| Scientific Title | Surgical treatment of thoracic adolescent idiopathic scoliosis with maintenance of kyphosis |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2015/05/08 14:41:59 |
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Basic information
Public title
Surgical treatment of thoracic adolescent idiopathic scoliosis with maintenance of kyphosis
Acronym
Surgical treatment of thoracic adolescent idiopathic scoliosis
Scientific Title
Surgical treatment of thoracic adolescent idiopathic scoliosis with maintenance of kyphosis
Scientific Title:Acronym
Surgical treatment of thoracic adolescent idiopathic scoliosis
Region
| Japan |
Condition
Condition
adolescent idiopathic scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the surgical outcomes of the simultaneous double-rod rotation technique for treating Lenke 1 thoracic adolescent idiopathic scoliosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient demographics, radiographic measurements, and Scoliosis Research Society questionnaire scores
Key secondary outcomes
Base
Study type
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
| Device,equipment | Maneuver |
Interventions/Control_1
surgical treatment
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
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
thoracic adolescent idiopathic scoliosis
Key exclusion criteria
syndromic, neuromuscular, and congenital scoliosis and the presence of other thoracic scoliosis curves such as double thoracic curves
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Sudo |
Organization
Hokkaido University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
North-15, West-7, Kita-ku, Sapporo, Hokkaido 060-8638, 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 Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
North-15, West-7, Kita-ku, Sapporo, Hokkaido 060-8638, 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 | 05 | Month | 08 | 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
| 2015 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 06 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020240
