UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020161 |
|---|---|
| Receipt number | R000023290 |
| Scientific Title | Comparison of Ti rod vs CoCr rod for treating AIS patients with posterior spinal fusion |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2015/12/17 13:07:31 |
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Basic information
Public title
Comparison of Ti rod vs CoCr rod for treating AIS patients with posterior spinal fusion
Acronym
Ti vs CoCr rod for treaying AIS patient
Scientific Title
Comparison of Ti rod vs CoCr rod for treating AIS patients with posterior spinal fusion
Scientific Title:Acronym
Ti vs CoCr rod for treaying AIS patient
Region
| Japan |
Condition
Condition
adolescent idiopathic scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy of CoCr rod
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Xp
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Ti or CoCr rod sold by STRYKER
Interventions/Control_2
postoperative follow up
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
Male and Female
Key inclusion criteria
AIS
Key exclusion criteria
non AIS
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsushi Takeshita |
Organization
Jichi medical university
Division name
orthopedics
Zip code
Address
Tochigi
TEL
0285-58-7374
otpdcs@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Sugawara |
Organization
Jichi medical univ.
Division name
orthopedics
Zip code
Address
Tochigi
TEL
0285-58-7374
Homepage URL
http://www.jichi.ac.jp/usr/orth/index.html
otpdcs@jichi.ac.jp
Sponsor or person
Institute
STRYKER
Institute
Department
Personal name
Funding Source
Organization
STRYKER
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
| 2015 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 25 | 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
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2015 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023290
