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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028114
Receipt No. R000032185
Scientific Title Comparison of decompression, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis: a prospective, randomized study
Date of disclosure of the study information 2017/07/06
Last modified on 2017/07/06

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Basic information
Public title Comparison of decompression, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis: a prospective, randomized study
Acronym A prospective randomized study of surgical treatment for degenerative spondylolisthesis
Scientific Title Comparison of decompression, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis: a prospective, randomized study
Scientific Title:Acronym A prospective randomized study of surgical treatment for degenerative spondylolisthesis
Region
Japan

Condition
Condition Degenerative spondylolisthesis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The selection of surgical procedure for lumbar spinal stenosis due to degenerative spondylolisthesis is still under debate. The purpose of this study is to prospectively assess the clinical results of decompression alone, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis.
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 JOA score, VAS, and SF-36 before surgery, at 1 year and 5, 10 years after surgery .
Key secondary outcomes Amount of bleeding, operation time, and radiological evaluations etc were evaluated

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Decompression
Interventions/Control_2 Decompression and fusion
Interventions/Control_3 Decompression and stabilization
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
75 years-old >=
Gender Male and Female
Key inclusion criteria One level lumbar spinal stenosis due to degenerative spondylolisthesis
Key exclusion criteria Previous history of lumbar spinal operation
Multilevel stenosis
Foraminal stenosis
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Inose
Organization Tokyo Medical and Dental University
Division name Department of Orthopedic Surgery
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5279
Email inose.orth@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Inose
Organization Tokyo Medical and Dental University
Division name Department of Orthopedic Surgery
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5279
Homepage URL
Email inose.orth@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization N/A
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
2017 Year 07 Month 06 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 Completed
Date of protocol fixation
2003 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2003 Year 09 Month 30 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
2017 Year 07 Month 06 Day
Last modified on
2017 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032185

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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