UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000040268
Receipt No. R000045938
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
Date of disclosure of the study information 2020/04/29
Last modified on 2021/04/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Main results already published
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
2021 Year 04 Month 30 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


Contact us.