UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040268 |
|---|---|
| Receipt number | 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 13:36:21 |
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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
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
takami@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045938
