UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Histological anyalysis of paraspinal muscle in adult spinal deformity patients
Title of the study (Brief title)	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	Yu Yamato
Organization	Hamamatsu University School of Medicine
Division name	Orthopaedic surgery
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL	053-435-2299
Email	yamato@hama-med.ac.jp

Public contact
Name of contact person	Tomohiro Banno
Organization	Hamamatsu University School of Medicine
Division name	Orthopaedic surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 11 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028400