UMIN-CTR Clinical Trial

Basic information
Public title	Simple measurement of the hindfoot alignment with the whole leg standing radiography
Acronym	Simple measurement of the hindfoot alignment with the whole leg standing radiography
Scientific Title	Simple measurement of the hindfoot alignment with the whole leg standing radiography
Scientific Title:Acronym	Simple measurement of the hindfoot alignment with the whole leg standing radiography
Region	Japan

Condition
Condition	Healthy subject
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish a simple method to assess the hindfoot alignment from the whole lower extremity X-ray images of healthy subjects.
Basic objectives2	Others
Basic objectives -Others	To measure the normal value of hindfoot alignment in whole lower extremity X-ray images of healthy subjects.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intra- and inter-examiner reliability of hindfoot alignment in the whole leg standing radiograph (the angle formed by the line connecting the tibial shaft and the center of the talus to the ground contact point of the calcaneus)
Key secondary outcomes	The normal value of hindfoot alignment in the whole leg standing radiograph (the angle formed by the line connecting the tibial shaft and the center of the talus to the ground contact point of the calcaneus)

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	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	Applicants must have no pain or other symptoms in the lower limbs (hip, knee, ankle, or foot) and no previous surgery for fracture or ligament injury.
Key exclusion criteria	Those with a BMI of 30 or more, flat feet or concave feet, general joint laxity, and those who are pregnant or may become pregnant
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Shuichi Middle name Last name Eto
Organization	Saga university hospital
Division name	Department of Orthopedic surgery
Zip code	8498501
Address	5-1-1 Nabeshima, Saga city, Saga, Japan.
TEL	0952342343
Email	shu.1.uhs0306@gmail.com

Public contact
Name of contact person	1st name Shuichi Middle name Last name Eto
Organization	Saga university hospital
Division name	Department of Orthopedic surgery
Zip code	8498501
Address	5-1-1 Nabeshima, Saga city, Saga, Japan.
TEL	0952342343
Homepage URL
Email	sagaseikei@gmail.com

Sponsor
Institute	Department of Orthopedic Surgery, Saga university hospital
Institute
Department

Funding Source
Organization	Department of Orthopedic Surgery, Saga university hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical research center, Saga university hospital
Address	5-1-1 Nabeshima, Saga city, Saga, Japan.
Tel	0952-34-3400
Email	kenkyu-shinsei@ml.cc.saga-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 09 Month 15 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	40
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	Main results already published
Date of protocol fixation	2019 Year 02 Month 13 Day
Date of IRB	2019 Year 02 Month 13 Day
Anticipated trial start date	2019 Year 02 Month 13 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	X-ray images are taken to measure the lower extremity alignment.

Management information
Registered date	2021 Year 09 Month 09 Day
Last modified on	2022 Year 03 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048894