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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018961
Receipt No. R000021941
Scientific Title A Study of Quantitative Evaluation of Muscle Atrophy and Fatty Infiltration of the Rotator Cuff Muscle using Magnetic Resonance Imaging
Date of disclosure of the study information 2015/09/10
Last modified on 2020/09/14

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Basic information
Public title A Study of Quantitative Evaluation of Muscle Atrophy and Fatty Infiltration of the Rotator Cuff Muscle using Magnetic Resonance Imaging
Acronym Quantitative Evaluation of Muscle Atrophy and Fatty Infiltration of the Rotator Cuff Muscle using Magnetic Resonance Imaging
Scientific Title A Study of Quantitative Evaluation of Muscle Atrophy and Fatty Infiltration of the Rotator Cuff Muscle using Magnetic Resonance Imaging
Scientific Title:Acronym Quantitative Evaluation of Muscle Atrophy and Fatty Infiltration of the Rotator Cuff Muscle using Magnetic Resonance Imaging
Region
Japan

Condition
Condition Rotator cuff tear
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A purpose of this study is to analyze the reliability of the way to measure entire volume of rotator cuff muscle using 3 dimensional magnetic resonance imaging.
Basic objectives2 Others
Basic objectives -Others Examination of the reliability
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes intra- and inter-observer reliability of the quantitative evaluation of rotator cuff muscle
Key secondary outcomes the correlation between the volume and cross-sectional area of the rotator cuff muscle

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Examination using magnetic resonance imaging for healthy subjct.
All subjects undergo the examination 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Healthy male without a past history of shoulder pain.
Key exclusion criteria Subject who cannot undergo MRI examination.
Subject who has a past history of nervous disease.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sasaki Tsuyoshi
Organization Gunma University Graduate School of Medicine
Division name Department of Orthopaedic surgery
Zip code
Address 3-39-22 Showa-town, Maebashi city, Gunma prefecture
TEL 027-220-8269
Email tsasaki@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sasaki Tsuhoshi
Organization Gunma University Graduate School of Medicine
Division name Department of Orthpaedic surgery
Zip code
Address 3-39-22 Showa-town, Maebashi city, Gunma prefecture
TEL 027-220-8269
Homepage URL
Email s244s244jp@yahoo.co.jp

Sponsor
Institute Department of orthopaedic surgery
Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of orthopaedic surgery
Gunma University Graduate School of Medicine
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
2015 Year 07 Month 22 Day
Anticipated trial start date
2015 Year 07 Month 22 Day
Last follow-up date
2017 Year 03 Month 15 Day
Date of closure to data entry
2017 Year 03 Month 15 Day
Date trial data considered complete
2017 Year 03 Month 15 Day
Date analysis concluded
2017 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date
2015 Year 09 Month 10 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021941

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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