UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044241 |
|---|---|
| Receipt number | R000050524 |
| Scientific Title | Comparison of Decompression, Decompression Plus Fusion, and Decompression Plus Stabilization for Degenerative Spondylolisthesis: Long-term follow-up of a prospective randomized study |
| Date of disclosure of the study information | 2021/05/20 |
| Last modified on | 2021/05/18 12:25:17 |
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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
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
inose.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050524
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
