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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000025144
Receipt No. 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

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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
Institute Tohoku university
Institute
Department

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
URL(English) https://upload.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


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