UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective RCT study of comparison the cervical laminoplasty and cervical laminoplasty with C3 laminectomy for cervical spondylosis myelopathy
Title of the study (Brief title)	Prospective RCT study of cervical laminoplasty with third C3 laminectomy
Region	Japan

Condition
Condition	Cervical spondylotic myelopathy
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effect of C3 laminectomy added in cervical laminoplasty by Hirabayashi method by comparing conventional cervical laminoplasty by Hirabayashi method for cervical spondylosis myelopathy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	JOA Cervical Myelopathy Evaluation Questionnaire (JOACMEQ)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	At the C3 lamina, laminectomy is performed.
Interventions/Control_2	At the C3 lamina, laminoplasty is performed.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The yellow race living in Japan who is diagnosed with cervical spondylosis myelopathy and who is scheduled for surgery. The surgery is cervical laminoplasty by Hirabayashi method (C3 from C6).
Key exclusion criteria	Patients who has posterior longitudinal ligament ossification, cervical spine trauma history, cervical spine surgery history, a disease which affects attitude reflex, such as Parkinson's disease.
Target sample size	120

Research contact person
Name of lead principal investigator	Masato Tanaka
Organization	Okayama University Hospital
Division name	The department of orthopedic surgery
Address	2-5-1 Shikata-cho, Okayama City, Okayama, Japan
TEL	086-235-7273
Email	tanakam@md.okayama-u.ac.jp

Public contact
Name of contact person	Yoshiaki Oda
Organization	Okayama University Hospital
Division name	The department of orthopedic surgery
Address	2-5-1 Shikata-cho, Okayama City, Okayama, Japan
TEL	086-235-7273
Homepage URL
Email	p0m27nbo@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Okayama University Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 02 Month 17 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 05 Day
Anticipated trial start date	2017 Year 03 Month 01 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	2017 Year 02 Month 17 Day
Last modified on	2017 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027644