UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025144
Receipt number R000028389
Scientific Title Kinetic analysis of joint structure using standing MRI
Date of disclosure of the study information 2017/01/01
Last modified on 2017/12/06 15:50:36

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Basic information

Public title

Kinetic analysis of joint structure using standing MRI

Acronym

Kinetic analysis of joint structure using standing MRI

Scientific Title

Kinetic analysis of joint structure using standing MRI

Scientific Title:Acronym

Kinetic analysis of joint structure using standing MRI

Region

Japan


Condition

Condition

Healthy knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Morphological assessment of joint structure in the weight bearing position

Basic objectives2

Others

Basic objectives -Others

Morphological assessment of joint structure in the weight bearing position

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Alignment and morphological parameters of joint structure in the weight bearing position

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Using standing MRI for healthy knee

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

18 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

volunteer

Key exclusion criteria

History with knee trauma and knee pain

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Hagiwara

Organization

Tohoku university Hospital

Division name

Department of Upper Extremity Musculoskeltal Medicine

Zip code


Address

1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi

TEL

022-717-7245

Email

hagi@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuyuki Itaya

Organization

Tohoku university Hospital

Division name

Department of Upper Extremity Musculoskeltal Medicine

Zip code


Address

1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi

TEL

022-717-7245

Homepage URL


Email

itaya.nobuyuki@gmail.com


Sponsor or person

Institute

Tohoku university

Institute

Department

Personal name



Funding Source

Organization

None

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

YES

Study ID_1

2016-1-379

Org. issuing International ID_1

Tohoku university

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東北大学病院


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 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

Suspended

Date of protocol fixation

2016 Year 10 Month 03 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 01 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

2016 Year 12 Month 05 Day

Last modified on

2017 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028389


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name