UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028227 |
|---|---|
| Receipt number | R000032308 |
| Scientific Title | Evaluation of Osteochondritis Dissecans of the elbow with three dimensional image constructed by fusion of MRI and CT -validation study to intra operative findings- |
| Date of disclosure of the study information | 2017/07/18 |
| Last modified on | 2017/07/13 22:35:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of Osteochondritis Dissecans of the elbow with three dimensional image constructed by fusion of MRI and CT -validation study to intra operative findings-
Acronym
Evaluation of Osteochondritis Dissecans of the elbow with three dimensional image constructed by fusion of MRI and CT.
Scientific Title
Evaluation of Osteochondritis Dissecans of the elbow with three dimensional image constructed by fusion of MRI and CT -validation study to intra operative findings-
Scientific Title:Acronym
Evaluation of Osteochondritis Dissecans of the elbow with three dimensional image constructed by fusion of MRI and CT.
Region
| Japan |
Condition
Condition
Osteochondritis dissecans of the elbow
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate created images and intra-operative findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The consistency of the created images and intra-operative findings.
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Traction is performed during MRI imaging, and three-dimensional reconstruction is performed from the obtained image.
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
Patients who visited Tsukuba University Hospital and associated facilities and diagnosed with osteochondritis dissecans from physical findings and x-rays,.
Key exclusion criteria
1 Patients who do not have voluntary consent ability
2 Patients who are unable to obtain written informed consent
3 Patients who can not conduct CT / MRI examination due to claustrophobia or the like
4 In addition, patients judged inappropriate by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Hara |
Organization
University of Tsukuba
Division name
Faculty of Medicine, Department of Orthopedic Surgery
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-853-3219
yukihara@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Kohyama |
Organization
University of Tsukuba
Division name
Faculty of Medicine, Department of Orthopedic Surgery
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-853-3219
Homepage URL
s1630421@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Mandatory accounting money
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
| 2017 | Year | 07 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 18 | 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
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2017 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032308
