UMIN-CTR Clinical Trial

Basic information
Public title	Development of a simple tool for flatfoot assessment
Acronym	Development of a simple tool for flatfoot assessment
Scientific Title	Development of a simple tool for flatfoot assessment
Scientific Title:Acronym	Development of a simple tool for flatfoot assessment
Region	Japan

Condition
Condition	flat foot
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine the usefulness of a simple tool developed to clearly and easily diagnose flat feet.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The subject will take a CT of the foot and then measure the distance between the scaphoid base and plantar skin in the center of the scaphoid in a sagittal section. They will then evaluate the arch height with the Simplified Flatfoot Assessment Tool and analyze whether there is an association between the two assessment methods. Compare the results of the Quick Assessment Tool with the image evaluation and evaluate the validity of the Quick Assessment Tool.
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient with CT scan of the foot
Key exclusion criteria	1) A history of lower extremity surgery 2) Any symptoms in the lower extremities
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Seikai Middle name Last name Toyooka
Organization	Teikyo University
Division name	Department of Orthopaedic Surgery
Zip code	1738606
Address	Kaga Itabashi Tokyo
TEL	03-3964-1211
Email	blueocean1092@hotmail.com

Public contact
Name of contact person	1st name Seikai Middle name Last name Toyooka
Organization	Teikyo University
Division name	Department of Orthopaedic Surgery
Zip code	1738606
Address	2-11-1 Kaga Itabashi Tokyo
TEL	0339641211
Homepage URL
Email	blueocean1092@hotmail.com

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	Teikyo University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Teikyo University
Address	2-11-1 Kaga Itabashi Tokyo
Tel	0339641211
Email	blueocean1092@hotmail.com

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	2020 Year 12 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	35
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	2020 Year 01 Month 01 Day
Date of IRB	2019 Year 11 Month 27 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The subject will take a CT of the foot and then measure the distance between the scaphoid base and plantar skin in the center of the scaphoid in a sagittal section. They will then evaluate the arch height with a simple flatfoot assessment tool and analyze whether there is an association between the two assessment methods.

Management information
Registered date	2020 Year 12 Month 10 Day
Last modified on	2020 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048759