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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000028227 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Osteochondritis dissecans of the elbow | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | University of Tsukuba |
Institute | |
Department |
Funding Source | |
Organization | Mandatory accounting money |
Organization | |
Division | |
Category of Funding Organization | Other |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032308 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |