UMIN-CTR Clinical Trial

Basic information
Public title	Development of diagnostic and therapeutic support tools for scoliosis using deep learning
Acronym	Development of diagnostic and therapeutic support tools for scoliosis using deep learning
Scientific Title	Development of diagnostic and therapeutic support tools for scoliosis using deep learning
Scientific Title:Acronym	Development of diagnostic and therapeutic support tools for scoliosis using deep learning
Region	Japan Asia(except Japan) North America Australia Europe

Condition
Condition	Scoliosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Image items related to the progression of scoliosis are evaluated using AI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	For X-ray images of patients with scoliosis, we will compare and examine which is more accurate, the progress prediction by AI or the progress prediction by a spine surgeon. We plan to use images from six months, one year, and two years to study the progress.
Key secondary outcomes	Images other than X-rays are also used as secondary outcomes. Patient groups are stratified and evaluated by degree of bone maturity.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	X-ray of 6, 12, and 24 months in patients with scoliosis was evaluated.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	idiopathic scoliosis
Key exclusion criteria	Exclude scoliosis from other disorders such as non-idiopathic, neurological, symptomatic, and congenital.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shoji Middle name Last name Seki
Organization	University of Toyama
Division name	Orthopaedic surgery
Zip code	930-0194
Address	Sugitani 2630
TEL	0764347353
Email	seki@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Shoji Middle name Last name Seki
Organization	University of Toyama
Division name	Orthopaedic surgery
Zip code	930-0194
Address	Sugitani 2630
TEL	0764347353
Homepage URL
Email	seki@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	Kakenhi
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Toyama
Address	Sugitani2630
Tel	0764347353
Email	seki@med.u-toyama.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	2022 Year 06 Month 10 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	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 01 Day
Date of IRB	2019 Year 09 Month 25 Day
Anticipated trial start date	2019 Year 09 Month 25 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 09 Day
Last modified on	2022 Year 06 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054722