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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007885
Receipt No. R000009286
Scientific Title Symptoms of navicular tuberosity are designated by an edema-like bone marrow pattern on magnetic resonance imaging in adolescents
Date of disclosure of the study information 2012/05/30
Last modified on 2012/05/06

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Basic information
Public title Symptoms of navicular tuberosity are designated by an edema-like bone marrow pattern on magnetic resonance imaging in adolescents
Acronym Magnetic resonance imaging for symptomatic accessory navicular bone
Scientific Title Symptoms of navicular tuberosity are designated by an edema-like bone marrow pattern on magnetic resonance imaging in adolescents
Scientific Title:Acronym Magnetic resonance imaging for symptomatic accessory navicular bone
Region
Japan

Condition
Condition symptomatic accessory navicular bone
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidation of pathophysiology and prompt diagnosis for symptomatic accessory navicular bone
Basic objectives2 Others
Basic objectives -Others Clinical improvement
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Intensity change in MRI
Key secondary outcomes

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
6 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria adolescents who have symptomatic accessory navicular
Key exclusion criteria nothing particular
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiko Takahashi
Organization University of Tokushima
Division name Department of Orthopaedics
Zip code
Address 3-18-15 Kuramoto, Tokushima
TEL 088-633-7240
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiko Takahashi
Organization University of Tokushima
Division name Department of Orthopaedics
Zip code
Address 3-18-15 Kuramoto, Tokushima
TEL 088-633-7240
Homepage URL
Email

Sponsor
Institute University of Tokushima
Institute
Department

Funding Source
Organization Tokushima Univerisy Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Suihou Diichi Hospital
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 徳島大学病院 Tokushima Univerisy Hospital
翠鳳第一病院 Suihou Diichi Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 30 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 Open public recruiting
Date of protocol fixation
2012 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 01 Month 01 Day

Other
Other related information Institute

Management information
Registered date
2012 Year 05 Month 03 Day
Last modified on
2012 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009286

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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