UMIN-CTR Clinical Trial

Basic information
Public title	Clinical outcomes of lateral lumbar interbody fusion after reduction using the percutaneous pedicle screw system in the lateral position for Meyerding grade II spondylolisthesis
Acronym	Clinical outcomes of lateral lumbar interbody fusion after reduction using the percutaneous pedicle screw system in the lateral position for Meyerding grade II spondylolisthesis
Scientific Title	Clinical outcomes of lateral lumbar interbody fusion after reduction using the percutaneous pedicle screw system in the lateral position for Meyerding grade II spondylolisthesis
Scientific Title:Acronym	Clinical outcomes of lateral lumbar interbody fusion after reduction using the percutaneous pedicle screw system in the lateral position for Meyerding grade II spondylolisthesis
Region	Japan

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

Objectives
Narrative objectives1	This study aimed to present clinical and radiological results of patients with spondylolisthesis of Meyerding grade II.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The operative time, blood loss, complications, visual analog scale of low back and leg pain, Oswestry Disability Index, JOA score, and radiological findings (changes of slippage, treated intervertebral heights, evaluation of endplate injury during surgery, malposition of the pedicle screws and screw loosening, inserted cage position in the interbody space, and bone union)
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Spondylolisthesis of Meyerding grade II or higher
Key exclusion criteria	N/A
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Masanari Middle name Last name Takami
Organization	Wakayama Medical University
Division name	Dept., of Orthop. Surg.
Zip code	6408510
Address	811-1 Kimiidera, Wakayama-city, Japan
TEL	073-441-0645
Email	takami@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Masanari Middle name Last name Takami
Organization	Wakayama Medical University
Division name	Dept., of Orthop. Surg.
Zip code	640-8510
Address	811-1 Kimiidera, Wakayama-city, Japan
TEL	073-441-0645
Homepage URL
Email	takami@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Dept., of Orthop. Surg., Wakayama Medical University
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	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama-city, Japan
Tel	073-447-2300
Email	wa-rinri@wakayama-med.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	2020 Year 04 Month 29 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	Open public recruiting
Date of protocol fixation	2020 Year 02 Month 25 Day
Date of IRB	2020 Year 02 Month 25 Day
Anticipated trial start date	2020 Year 02 Month 25 Day
Last follow-up date	2025 Year 02 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2020 Year 04 Month 29 Day
Last modified on	2020 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045938

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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