UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Osteochondritis Dissecans of the elbow with three dimensional image constructed by fusion of MRI and CT -validation study to intra operative findings-
Acronym	Evaluation of Osteochondritis Dissecans of the elbow with three dimensional image constructed by fusion of MRI and CT.
Scientific Title	Evaluation of Osteochondritis Dissecans of the elbow with three dimensional image constructed by fusion of MRI and CT -validation study to intra operative findings-
Scientific Title:Acronym	Evaluation of Osteochondritis Dissecans of the elbow with three dimensional image constructed by fusion of MRI and CT.
Region	Japan

Condition
Condition	Osteochondritis dissecans of the elbow
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to validate created images and intra-operative findings.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The consistency of the created images and intra-operative findings.
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	Maneuver
Interventions/Control_1	Traction is performed during MRI imaging, and three-dimensional reconstruction is performed from the obtained image.
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 who visited Tsukuba University Hospital and associated facilities and diagnosed with osteochondritis dissecans from physical findings and x-rays,.
Key exclusion criteria	1 Patients who do not have voluntary consent ability 2 Patients who are unable to obtain written informed consent 3 Patients who can not conduct CT / MRI examination due to claustrophobia or the like 4 In addition, patients judged inappropriate by the attending physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuki Hara
Organization	University of Tsukuba
Division name	Faculty of Medicine, Department of Orthopedic Surgery
Zip code
Address	Tennodai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
TEL	029-853-3219
Email	yukihara@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Sho Kohyama
Organization	University of Tsukuba
Division name	Faculty of Medicine, Department of Orthopedic Surgery
Zip code
Address	Tennodai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
TEL	029-853-3219
Homepage URL
Email	s1630421@u.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Mandatory accounting money
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
Address
Tel
Email

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 07 Month 18 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	Preinitiation
Date of protocol fixation	2017 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 13 Day
Last modified on	2017 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032308

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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