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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017899
Receipt No. R000013056
Scientific Title Prospective Multicenter Study for Spontaneous Anterior Interosseous Nerve Palsy and Spontaneous Posterior Interosseous Nerve Palsy
Date of disclosure of the study information 2015/06/20
Last modified on 2015/06/14

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Basic information
Public title Prospective Multicenter Study for Spontaneous Anterior Interosseous Nerve Palsy and Spontaneous Posterior Interosseous Nerve Palsy
Acronym Prospective Multicenter Study for Spontaneous Anterior Interosseous Nerve Palsy and Spontaneous Posterior Interosseous Nerve Palsy
Scientific Title Prospective Multicenter Study for Spontaneous Anterior Interosseous Nerve Palsy and Spontaneous Posterior Interosseous Nerve Palsy
Scientific Title:Acronym Prospective Multicenter Study for Spontaneous Anterior Interosseous Nerve Palsy and Spontaneous Posterior Interosseous Nerve Palsy
Region
Japan

Condition
Condition Spontaneous anterior and posterior interosseous nerve palsy
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the pathophysiology and treatment of spontaneous anterior interosseous nerve palsy and spontaneous posterior interosseous nerve palsy
Basic objectives2 Others
Basic objectives -Others To clarify the pathophysiology, prognosis, and optimum treatment of spontaneous anterior interosseous nerve palsy and posterior interosseous nerve palsy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the clinical findings, palsy types, treatment options and prognosis of these treatments and if surfical treatment is selected, we will evaluate the surgical findings
Key secondary outcomes

Base
Study type

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 Treatment
Type of intervention
Other
Interventions/Control_1 Neurolysis is indicated for the patients who require the surgical treatment in spite of the period from the onset
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 diagnosed as spontaneous anterior interossous nerve palsy and posterior interosseous nerve palsy, and the patients who participated in this study.
Key exclusion criteria 1)patients who suffered from svere heart disease, liver disease, and renal disease.
2)patients who have no ability for intension of consenting
3)patients who are impossible to obtain the written agreement.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Kato
Organization Department of orthopaedic surgery, Shinshu University
Division name Orthopaedic department
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-35-8844
Email Hirokato@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rikuo Shinomiya
Organization Department of orthopaedic surgery, Hiroshima University
Division name Orthopaedic department
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5233
Homepage URL
Email shinomi0123@yahoo.co.jp

Sponsor
Institute interosseous nerve palsy study Japan: iNPS-Japan
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
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
2015 Year 06 Month 20 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
2013 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 24 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
2015 Year 06 Month 14 Day
Last modified on
2015 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013056

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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