UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Spinal system multicenter RCT study for Idiopathic Scoliosis
Title of the study (Brief title)	Deformity study
Region	Japan

Condition
Condition	Idiopathic Scoliosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This objective of this study is to compare the postoperative correction rate between the use of Vitallium rod and that of Titanium alloy rod in Idiopathic Scoliosis patients at one year after surgery.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The correction rate of Cobb angle after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Titanium Alloy group
Interventions/Control_2	Vitallium group
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	19 years-old >=
Gender	Female
Key inclusion criteria	1. Patient who have an Idiopathic Scoliosis. 2. Patient whose pre-operative Cobb angle is greater than 45 degrees. 3. Lenke type 1, 2 and 3. 4. Patient whose age is between 10 and 19 years age. 5. Female. 6. Ability to read and understand Japanese. 7. Patient and legally authorized representative can provide voluntary informed consent.
Key exclusion criteria	1. Patients who have abnormal bone remodeling. 2. Patients who had previous spine surgery and second surgery. 3. Patients who are pregnant or potential pregnancy. 4. Patients who have Infection related disease. 5. Patients who have non healing open wounds. 6. Patients who have serious metal allergy related diseases. 7. Patients who has a diagnosed neuromuscular deficit.
Target sample size	80

Research contact person
Name of lead principal investigator	Katsushi Takeshita
Organization	Tokyo University
Division name	orthopedics
Address	Hongo Bunkyo-ku, Tokyo
TEL	03-5800-6520
Email	dtstake@gmail.com

Public contact
Name of contact person	yuko.komori
Organization	Stryker Japan
Division name	Clinical affairs
Address	Koraku, Bunkyo-ku, Tokyo
TEL	03-6894-8322
Homepage URL
Email	yuko.komori@stryker.com

Sponsor
Institute	Stryker Japan
Institute
Department

Funding Source
Organization	Stryker Japan
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	2012 Year 09 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 23 Day
Anticipated trial start date	2012 Year 07 Month 24 Day
Last follow-up date
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

Management information
Registered date	2012 Year 09 Month 03 Day
Last modified on	2017 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010383