UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of diagnosis and treatment evaluation of leg and foot fatigue fractures by X-ray grating interferometer (Talbot-Lau interferomete)
Title of the study (Brief title)	Examination of diagnosis and treatment evaluation of leg and foot fatigue fractures by X-ray grating interferometer (Talbot-Lau interferomete)
Region	Japan

Condition
Condition	Fatigue fractures of leg and foot
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, fatigue fractures of the tibia and metatarsal bones were diagnosed using a Talbot-Lau interferometer, and by comparing the effectiveness of diagnosis with simple X-ray image, MRI image and CT image, To evaluate the effectiveness in the early diagnosis and treatment evaluation of fatigue fractures and the safety of the device
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic rate of lower limb fatigue fracture by Talbot-Lau interferometer
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Imaging by Talbot-Low interferometer
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who are aged 20 or over and under 70 years of age at the time of acquiring consent 2) Case in which fatigue fracture is suspected with localized pain, tenderness in the lower leg, feet due to repeated exercise load 3) Patient who signed consent form
Key exclusion criteria	1) Patients who wish to be pregnant or pregnant 2) Persons who are participating in other clinical studies 3) In addition, the patient who the doctor in charge judged as undesirable as the subject of this study
Target sample size	40

Research contact person
Name of lead principal investigator	Yu Mori
Organization	Tohoku University Hospital
Division name	Department of Orthopeadic Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	0227177245
Email	yu-mori@med.tohoku.ac.jp

Public contact
Name of contact person	Yu Mori
Organization	Tohoku University Hospital
Division name	Department of Orthopeadic Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	0227177245
Homepage URL
Email	yu-mori@med.tohoku.ac.jp

Sponsor
Institute	Department of Orthopeadic Surgery, Tohoku University Hospital
Institute
Department

Funding Source
Organization	Department of Orthopaedic Surgery, Tohoku University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 08 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 08 Month 30 Day
Anticipated trial start date	2017 Year 09 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 30 Day
Last modified on	2019 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033075