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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008838
Receipt No. R000010383
Scientific Title Spinal system multicenter RCT study for Idiopathic Scoliosis
Date of disclosure of the study information 2012/09/07
Last modified on 2017/09/06

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Basic information
Public title Spinal system multicenter RCT study for Idiopathic Scoliosis
Acronym Deformity study
Scientific Title Spinal system multicenter RCT study for Idiopathic Scoliosis
Scientific Title:Acronym 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
1st name
Middle name
Last name Katsushi Takeshita
Organization Tokyo University
Division name orthopedics
Zip code
Address Hongo Bunkyo-ku, Tokyo
TEL 03-5800-6520
Email dtstake@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name yuko.komori
Organization Stryker Japan
Division name Clinical affairs
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2012 Year 04 Month 23 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010383

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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