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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032870
Receipt No. R000037478
Official scientific title of the study 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 2018/06/05

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Basic information
Official scientific title of the study Retrospective Clinical Study on Efficacy and Safety of Growing Rod Method for the treatment of Early Onset Scoliosis
Title of the study (Brief title) 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 Kaoru Furuya
Organization Medtronic Sofamor Danek, Co.,Ltd.
Division name Regulatory and Clinical Affairs
Address KM Nishi-Umeda Building 7-20-1 Fukushima, Fukushima-ku, Osaka, Japan
TEL 03-6430-7700
Email kaoru.furuya@medtronic.com

Public contact
Name of contact person Kaoru Furuya
Organization Medtronic Sofamor Danek, Co.,Ltd.
Division name Regulatory and Clinical Affairs
Address Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo, Japan
TEL 03-6776-0092
Homepage URL
Email kaoru.furuya@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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 26 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037478

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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