UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Decompression, Decompression Plus Fusion, and Decompression Plus Stabilization for Degenerative Spondylolisthesis: Long-term follow-up of a prospective randomized study
Acronym	Long-term follow-up of a prospective randomized study of Degenerative Spondylolisthesis
Scientific Title	Comparison of Decompression, Decompression Plus Fusion, and Decompression Plus Stabilization for Degenerative Spondylolisthesis: Long-term follow-up of a prospective randomized study
Scientific Title:Acronym	Long-term follow-up of a prospective randomized study of Degenerative Spondylolisthesis
Region	Japan

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

Objectives
Narrative objectives1	To clarify the long-term results of surgery for Degenerative Spondylolisthesis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	L-JOA score at final follow-up
Key secondary outcomes	Patient satisfaction VAS score(lower back pain, lower extremity pain) SF-36

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	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 Patients who are unable to complete the questionnaire due to dementia
Target sample size	85

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Inose
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic Surgery
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo Japan
TEL	03-5803-5279
Email	inose.orth@tmd.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Inose
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic Surgery
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo Japan
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	Ethics Committee, Faculty of Medicine, Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo Japan
Tel	03-3813-6111
Email	syomu1.adm@tmd.ac.jp

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	2021 Year 05 Month 20 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	66
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	No longer recruiting
Date of protocol fixation	2020 Year 07 Month 23 Day
Date of IRB	2020 Year 07 Month 23 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We will compare the long-term results of the participants of the randomized controlled trial of "Comparison of decompression, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis: a prospective, randomized study", which we led, by questionnaires and radiological examination to clarify the long-term outcome of surgery for degenerative spondylolisthesis.

Management information
Registered date	2021 Year 05 Month 18 Day
Last modified on	2021 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050524