UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The usefulness of ster EOS imaging system for hip diseases
Title of the study (Brief title)	The usefulness of EOS for hip diseases
Region	Japan

Condition
Condition	hip diseases
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The usefullness of EOS for hip diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	measured value of EOS images
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	two years
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with hip diseases
Key exclusion criteria	cases with difficulty of standing
Target sample size	150

Research contact person
Name of lead principal investigator	Yutaka Inaba
Organization	Yokohama City University
Division name	Orthopaedic surgery
Address	3-9 Fukuuram Kanazawa-ku, Yokohama, Japan
TEL	045-787-2655
Email	yute0131@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Hiroyuki Ike
Organization	Yokohama City University
Division name	Orthopaedic surgery
Address	3-9 Fukuuram Kanazawa-ku, Yokohama, Japan
TEL	045-787-2655
Homepage URL
Email	hi_ike3@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	none
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	横浜市立大学付属病院

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 07 Month 04 Day
Anticipated trial start date	2014 Year 07 Month 04 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	2015 Year 01 Month 19 Day
Last modified on	2017 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018869