UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007885
Receipt number 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 12:18:10

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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 or person

Institute

University of Tokushima

Institute

Department

Personal name



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

Value
https://center6.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