UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032870 |
|---|---|
| Receipt number | R000037478 |
| Scientific Title | Retrospective Clinical Study on Efficacy and Safety of Growing Rod Method for the treatment of Early Onset Scoliosis |
| Date of disclosure of the study information | 2018/06/06 |
| Last modified on | 2019/10/29 15:37:16 |
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Basic information
Public title
Retrospective Clinical Study on Efficacy and Safety of Growing Rod Method for the treatment of Early Onset Scoliosis
Acronym
Retrospective Clinical Study for the Growing Rod Method
Scientific Title
Retrospective Clinical Study on Efficacy and Safety of Growing Rod Method for the treatment of Early Onset Scoliosis
Scientific Title:Acronym
Retrospective Clinical Study for the Growing Rod Method
Region
| Japan |
Condition
Condition
Early Onset Scoliosis
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect and summarize the data of Cobb angle and kyphosis angle at preoperative timepoint and postoperative 24 months timepoint for the patients treated by any growing rod method as well as to evaluate change of Cobb angle and kyphosis angle at 24 months from preoperative visit
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate efficacy on degree of scoliosis correction from preoperative visit for Cobb angle(Major/Minor) and kyphosis angle(T2-T5, T5-T12, T10-T12, T12-S1) at postoperative 24 months
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
| 10 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Diagnosed as early onset scoliosis and received a treatment of growing rod method
(2)Under 10 years old at initial surgery
(3)Received a treatment of growing rod method as initial surgery at a collaborative investigational sites.
Key exclusion criteria
(1)Patient from whom written or verbal consent was not obtained in participation of this study
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | Asami |
| Middle name | |
| Last name | Taguchi |
Organization
Medtronic Sofamor Danek, Co.,Ltd.
Division name
Regulatory and Clinical Affairs
Zip code
108-0075
Address
Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo, Japan
TEL
03-6776-0018
asami.taguchi@medtronic.com
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Taguchi |
Organization
Medtronic Sofamor Danek, Co.,Ltd.
Division name
Regulatory and Clinical Affairs
Zip code
108-0075
Address
Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo, Japan
TEL
03-6776-0352
Homepage URL
asami.taguchi@medtronic.com
Sponsor or person
Institute
Medtronic Sofamor Danek, Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Medtronic Sofamor Danek, Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medtronic Sofamor Danek, Co.,Ltd.
Address
Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo, Japan
Tel
03-6776-0352
asami.taguchi@medtronic.com
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
| 2018 | Year | 06 | Month | 06 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collection items for safety
Date of additional surgery,reason of additional surgery,description and outcome of adverse event or deficiency lead to additional surgery
Management information
Registered date
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037478
