UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008838 |
|---|---|
| Receipt number | 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 09:07:26 |
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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
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
yuko.komori@stryker.com
Sponsor or person
Institute
Stryker Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010383
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
