UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043169 |
|---|---|
| Receipt number | R000049275 |
| Scientific Title | Research on mobile application software for school scoliosis screening |
| Date of disclosure of the study information | 2021/01/28 |
| Last modified on | 2022/12/01 07:51:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on mobile application software for school scoliosis screening
Acronym
Research on mobile application software for school scoliosis screening
Scientific Title
Research on mobile application software for school scoliosis screening
Scientific Title:Acronym
Research on mobile application software for school scoliosis screening
Region
| Japan |
Condition
Condition
Scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of scoliosis: By using the developed image analysis software, the goal is to improve the screening accuracy of school examinations even for physicians who are not orthopedists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of spinal deformity with image analysis software, spinal deformity angle with plain standing spine X-ray image
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited our outpatient department for scoliosis or scoliosis due to scoliosis or suspicion of it.
Key exclusion criteria
Patients who are pregnant or may become pregnant.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Akazawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
cds00350@par.odn.ne.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Akazawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
cds00350@par.odn.ne.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AOSpine
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Swiss
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
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
| 2021 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.cureus.com/articles/52774-mobile-application-for-scoliosis-screening-using-a-standard-2d
Number of participants that the trial has enrolled
3
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 17 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 01 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049275
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
