UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020899
Receipt number R000024111
Scientific Title Ankle joint Capsule Injury: MRI study
Date of disclosure of the study information 2016/02/05
Last modified on 2022/08/24 13:47:42

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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 Kentaro
Middle name
Last name Amaha

Organization

St Luke's International Hospital

Division name

Orthopaedics Surgery

Zip code

1048560

Address

9-1Akashicho, Chuo-ku, Tokyo, Japan

TEL

03-3541-5151

Email

amaken@luke.ac.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Amaha

Organization

St Luke's International Hospital

Division name

Orthopaedics Surgery

Zip code

1048560

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 or person

Institute

St Luke's International Hospital

Institute

Department

Personal name



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

St Luke's International Hospital Institutional Review Board

Address

Akashicho 9-1, Chuo-ku, Tokyo, Japan

Tel

03-3541-5151

Email

listnerkenkyu@luke.ac.jp


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

https://research.luke.ac.jp/handling/clinicalresearch/2017.html

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

30

Results

in the process of being written

Results date posted

2022 Year 08 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

in the process of being written

Participant flow

in the process of being written

Adverse events

in the process of being written

Outcome measures

in the process of being written

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

2022 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024111


Research Plan
Registered date File name
2024/02/11 足MRI研究計画書4.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name