UMIN-CTR Clinical Trial

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
Email	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
Email	cds00350@par.odn.ne.jp

Sponsor
Institute	Department of Orthopaedic Surgery, St. Marianna University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049275