UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018961 |
|---|---|
| Receipt number | 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 12:28:48 |
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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
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
s244s244jp@yahoo.co.jp
Sponsor or person
Institute
Department of orthopaedic surgery
Gunma University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021941
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
