UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053249 |
|---|---|
| Receipt number | R000059450 |
| Scientific Title | Efficacy of indirect decompression for unstable lumbar degenerative spondylolisthesis: indirect decompression versus direct decompression |
| Date of disclosure of the study information | 2023/12/28 |
| Last modified on | 2023/12/28 12:07:15 |
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Basic information
Public title
Efficacy of indirect decompression for unstable lumbar degenerative spondylolisthesis: indirect decompression versus direct decompression
Acronym
Efficacy of indirect decompression for unstable lumbar degenerative spondylolisthesis
Scientific Title
Efficacy of indirect decompression for unstable lumbar degenerative spondylolisthesis: indirect decompression versus direct decompression
Scientific Title:Acronym
Efficacy of indirect decompression for unstable lumbar degenerative spondylolisthesis
Region
| Japan |
Condition
Condition
degenerative lumbar spondylolisthesis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical outcomes of indirect decompression compared to direct decompression in lateral entry intervertebral fusion for unstable lumbar degenerative spondylolisthesis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of functional outcome (Oswestry Disability Index) at 2 years postoperatively
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
lateral lumbar interbody fusion (indirect decompression)
Interventions/Control_2
lateral lumbar interbody fusion (direct decompression)
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with lumbar degenerative spondylolisthesis (Grade 1 or 2) between one vertebra diagnosed by simple lumbar spine X-ray and MRI
2) Patients with symptomatic (cauda equina or nerve root symptoms) lumbar spinal canal stenosis
(iii) Patients with intervertebral instability (worsening of slip of 3 mm or more on simple lumbar spine X-ray with anterior-posterior flexion)
(iv) Patients who are 45 years of age or older at the time of consent/enrollment
(5) Written consent for participation in the study has been obtained from the patients themselves.
Key exclusion criteria
(i) Has undergone surgery for lumbar degenerative spondylolisthesis
(2) Severe infection and other serious complications (American Society of Anesthesiologists
Class 3 or higher)
(iii) Other patients who are judged to be inappropriate for this study by the Principal Investigator or a Research Associate.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Kyoto University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
6068507
Address
Kawaharamachi, Syogoin, Sakyo, Kyoto
TEL
0757513111
takayosh@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Kyoto University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
6068507
Address
Kawaharamachi, Syogoin, Sakyo, Kyoto
TEL
0757513111
Homepage URL
takayosh@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Shimizu Takayoshi
Funding Source
Organization
None
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
Kyoto University, Ethics Committie
Address
Yoshida Konoecho, Sakyo, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2029 | Year | 01 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059450
| 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 |
