UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005826 |
|---|---|
| Receipt number | R000006888 |
| Scientific Title | Analysis of shoulder, elbow, wrist, hip, knee, and ankle joint using MRI after direct injection of gadolinium |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2014/06/21 09:22:13 |
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Basic information
Public title
Analysis of shoulder, elbow, wrist, hip, knee, and ankle joint using MRI after direct injection of gadolinium
Acronym
Analysis of joint using MRI after direct injection of gadolinium
Scientific Title
Analysis of shoulder, elbow, wrist, hip, knee, and ankle joint using MRI after direct injection of gadolinium
Scientific Title:Acronym
Analysis of joint using MRI after direct injection of gadolinium
Region
| Japan |
Condition
Condition
pathological change of shoulder, elbow, wrist, hip, knee, and ankle joints
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
MRI is useful examination to show the pathological change of soft tissue. We can suggest the possibility of the injury of the labrum, joint capsule, and ligament in the joint, but we cannot detect sufficiently in plain MRI. The purpose of this study is to analyse that whether we could detect the pathological change in the joints using MRI after direct injection of gadolinium.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The presense of pathological change of in the joints.
The success rate of injection of gadolinium in the joint.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
single injection
gadolinium 0.3ml
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
the patients with the pain of shoulder, elbow, wrist, hip, knee, or ankle joints.
Key exclusion criteria
the patient with infection, malignant tumor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoatsu Kimura |
Organization
Faculty of Medicine, University of Toyama
Division name
Orthopaedic Surgery
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7353
tkimura@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito Sugimori |
Organization
Faculty of Medicine, University of Toyama
Division name
Orthopaedic Surgery
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7353
Homepage URL
ksugi@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
富山大学附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 21 | Day |
Last modified on
| 2014 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006888
