UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037714 |
|---|---|
| Receipt number | R000043013 |
| Scientific Title | The experience of spinal fusion with lateral interbody fusion |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2023/01/01 12:33:49 |
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Basic information
Public title
The experience of spinal fusion with lateral interbody fusion
Acronym
The experience of spinal fusion with lateral interbody fusion
Scientific Title
The experience of spinal fusion with lateral interbody fusion
Scientific Title:Acronym
The experience of spinal fusion with lateral interbody fusion
Region
| Japan |
Condition
Condition
lumbar spinal stenosis and degenerative spondylolisthesis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine whether there was a difference in bone fusion rate or cage subsidence between bilateral versus unilateral fixation after LIF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone fusion rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
bilateral Percutaneous pedicle screw
Interventions/Control_2
unilateral Percutaneous pedicle screw
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
DEXA:YAM>70%
Key exclusion criteria
Patients who are judged inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Hiyama |
Organization
Tokai University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
259-1193
Address
143 Shimokasuya Isehara Kanagawa
TEL
0463-93-1121
a.hiyama@tokai-u.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Hiyama |
Organization
Tokai University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
259-1193
Address
143 Shimokasuya Isehara Kanagawa
TEL
0463-93-1121
Homepage URL
a.hiyama@tokai-u.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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
Tokai University School of Medicine
Address
143 Shimokasuya Isehara Kanagawa
Tel
0463-93-1121
a.hiyama@tokai-u.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
| 2019 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043013
