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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020899
Receipt No. R000024111
Scientific Title Ankle joint Capsule Injury: MRI study
Date of disclosure of the study information 2016/02/05
Last modified on 2017/02/05

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Basic information
Public title Ankle joint Capsule Injury: MRI study
Acronym Ankle Joint Capsule Injury: MRI study
Scientific Title Ankle joint Capsule Injury: MRI study
Scientific Title:Acronym Ankle Joint Capsule Injury: MRI study
Region
Japan

Condition
Condition diseases cause ankle pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Rupture of ankle joint capsule
Basic objectives2 Others
Basic objectives -Others Location and severity of ankle joint capsule rupture
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Interpretation of Artho-MRI of ankle joint
Key secondary outcomes symptom

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Ankle arthro-MRI oneday,once
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 need MRI examination
Key exclusion criteria patients who are contraindecated for MRI
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Amaha
Organization St Luke's International Hospital
Division name Orthopaedics Surgery
Zip code
Address 9-1Akashicho, Chuo-ku, Tokyo, Japan
TEL 03-3541-5151
Email amaken@luke.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Amaha
Organization St Luke's International Hospital
Division name Orthopaedics Surgery
Zip code
Address 9-1 Akashicho, Chuo-ku, Tokyo, Japan
TEL 03-3541-5151
Homepage URL http://crc.luke.ac.jp/processresearcher/schedule.html
Email amaken@luke.ac.jp

Sponsor
Institute St Luke's International Hospital
Institute
Department

Funding Source
Organization no fund
Organization
Division
Category of Funding Organization Non profit foundation
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 聖路加国際病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 05 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
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
2017 Year 03 Month 01 Day
Date of closure to data entry
2017 Year 03 Month 01 Day
Date trial data considered complete
2017 Year 03 Month 01 Day
Date analysis concluded
2017 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 05 Day
Last modified on
2017 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024111

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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