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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001989
Receipt No. R000002425
Scientific Title Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis.
Date of disclosure of the study information 2009/05/21
Last modified on 2009/05/21

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Basic information
Public title Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis.
Acronym Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis.
Scientific Title Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis.
Scientific Title:Acronym Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis.
Region
Japan

Condition
Condition vertebral bone metasitasis,
pyogenic spondylarthritis
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the difference of extradural expansoin between vertebral bone metastasis and pyogenic spondylarthritis, using MRI.
Basic objectives2 Others
Basic objectives -Others To evaluate extradural expansion forms and compression type of dura mater in MRI.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Using MRI, for example, sagital and axail view of T1 and T2 intensity, estimate
extradural expansion of metastasis and infection.
Key secondary outcomes To estimate MRI of spine, when taking at severe clinical symptoms.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 of vertebral bone metastasis, or pyogenic infection of spine.
Key exclusion criteria Exclusion of primary bone tumor, and spondylarthritis without pyogenic infection.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Imabayashi
Organization National diffence of medical collage
Division name Orthopedic
Zip code
Address Namiki 3-2, Tokorozawa City, Saitama prefecture
TEL 04-2995-1663
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Imabayashi
Organization National Diffence of medical collage
Division name Orthopedic
Zip code
Address Namiki 3-2, Tokorozawa City, Saitama Prefecture
TEL 04-2995-1211
Homepage URL
Email hidk693@ndmc.ac.jp

Sponsor
Institute National Diffence of Medical Collage
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 05 Month 21 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
2009 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation of extradural expansion of vertebral metastasis, pyogenic infection of spine. That are supposed to relate clinical findings,especially progressing paralysis.

Management information
Registered date
2009 Year 05 Month 21 Day
Last modified on
2009 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002425

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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