UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of anterior decompression with fusion and posterior decompression with laminoplasty for the treatment of cervical spondylotic myelopathy
Title of the study (Brief title)	A prospective comparative study for CSM
Region	Japan

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

Objectives
Narrative objectives1	Anterior decompression with fusion (ADF) and posterior decompression with laminoplasty (LAMP) are both effective surgical procedures for cervical spondylotic myelopathy (CSM). Previously we reported that ADF provided superior neurologic outcomes to LAMP at 5 years after operation. In this study, we update the data to assess long-term clinical and radiologic outcomes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical outcomes were evaluated by comparing the recovery rate of the Japanese Orthopaedic Association (JOA) score between the two groups. Radiographs were taken before surgery and every year after surgery. Sagittal alignment of the C2-7 lordotic angle and range of motion (ROM) in flexion and extension were measured before and after surgery.
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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Anterior decompression with fusion
Interventions/Control_2	Posterior decompression with laminoplasty
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Cervical spondylotic myelopathy
Key exclusion criteria	Patients with myelopathy caused by cervical disc herniation and ossification of the posterior longitudinal ligament (OPLL), those with radiculopathy, and those with a history of previous cervical spine surgery or injury
Target sample size	90

Research contact person
Name of lead principal investigator	Takashi Hirai
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic Surgery
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Email	hirai.orth@tmd.ac.jp

Public contact
Name of contact person	Takashi Hirai
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic Surgery
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Homepage URL
Email	hirai.orth@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 08 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	1996 Year 01 Month 01 Day
Anticipated trial start date	1996 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 08 Month 01 Day

Related information
URL releasing protocol	http://www.ncbi.nlm.nih.gov/pubmed/21289554
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 01 Day
Last modified on	2016 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026999