UMIN-CTR Clinical Trial

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
Email	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
Email	asami.taguchi@medtronic.com

Sponsor
Institute	Medtronic Sofamor Danek, Co.,Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037478