UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Recovery Process in Patients with Cervical Laminoplasty
Title of the study (Brief title)	Recovery Process Using JOACMEQ
Region	Japan

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

Objectives
Narrative objectives1	Hypothesis is made that the tendency of recovery process using the conventional JOA score and JOACMEQ, a patient-based evaluation, are different. Our object is to investigate the functional recovery process with laminoplasty performed to CSM using JOACMEQ.
Basic objectives2	Others
Basic objectives -Others	Our object is to clarify the relationship between the image evaluation using Xp, MRI, etc. and the improvement of the function after the operation.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	For the same patient, JOACMEQ are scored at each time point before operation, 1 month, 3 months, 6 months, 1 year and 2 years after operation. And we consider trends of recovery for each domain.
Key secondary outcomes	From image evaluation before and after operation, factors influencing postoperative results will be examined.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases of performed cervical laminoplasty for cervical spondylosis myelopathy
Key exclusion criteria	1. Under 19 years old cases 2. Cases in which the postoperative evaluations are missed at least one point during 2 years after the operation 3. Infection 4. Dialysis cases 5. Trauma cases
Target sample size	60

Research contact person
Name of lead principal investigator	Hideki Shigematsu
Organization	Nara medical university
Division name	Orthopedic Surgery
Address	840 Shijyo-cho, Kashihara shi, Nara Prefecture
TEL	0744-22-3051
Email	shideki@naramed-u.ac.jp

Public contact
Name of contact person	Hideki Shigematsu
Organization	Nara medical university
Division name	Orthopedic Surgery
Address	840 Shijyo-cho, Kashihara shi, Nara Prefecture
TEL	0744-22-3051
Homepage URL
Email	shideki@naramed-u.ac.jp

Sponsor
Institute	Nara medical university Orthopedic Surgery
Institute
Department

Funding Source
Organization	Nara medical university Orthopedic 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	奈良県立医科大学（奈良県）、香芝旭ヶ丘病院（奈良県）

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 24 Day
Anticipated trial start date	2018 Year 07 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	Observational study to evaluate postoperative recovery process

Management information
Registered date	2018 Year 04 Month 21 Day
Last modified on	2018 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036873