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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024684
Receipt No. R000028400
Scientific Title Histological anyalysis of paraspinal muscle in adult spinal deformity patients
Date of disclosure of the study information 2016/11/08
Last modified on 2018/11/05

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Basic information
Public title Histological anyalysis of paraspinal muscle in adult spinal deformity patients
Acronym Back musle assessment in adult spinal deformity
Scientific Title Histological anyalysis of paraspinal muscle in adult spinal deformity patients
Scientific Title:Acronym Back musle assessment in adult spinal deformity
Region
Japan

Condition
Condition adult spinal deformity
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the histology of paraspinal muscle in adult spinal deformity patients
Basic objectives2 Others
Basic objectives -Others Radiological parameter, cross sectional area of paraspinal muscle by MRI, gait anylysis, electrophysiologic assessment by surface electromyography
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Histological analysis of paraspinal muscle and neuromusclar junction
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver Other
Interventions/Control_1 To collect the paraspinal muscle of spinal deformity patients from intraoperative field
Interventions/Control_2 To collect the paraspinal muscle of spinal disease patients without deformity from intraoperative field
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Adult spinal deformity patients who underwent corrective surgery in our hospital
2. The patients who underwent spinal surgery without deformiy for control group
3. The patients who agree with our study
Key exclusion criteria 1. The patients who are determined as inadequate
2. The patients who disagree with our study
3. The patients who has conjenital spinal disease, syndromic spinal disease, or infectional spinal disease
4. reopreration case
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yu Yamato
Organization Hamamatsu University School of Medicine
Division name Orthopaedic surgery
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL 053-435-2299
Email yamato@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Banno
Organization Hamamatsu University School of Medicine
Division name Orthopaedic surgery
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL 053-435-2299
Homepage URL
Email tomohiro.banno0311@gmail.com

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
Department of Orthopaedic surgery
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
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
2016 Year 11 Month 08 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 Terminated
Date of protocol fixation
2016 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 08 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
2016 Year 11 Month 02 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028400

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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