UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044893 |
|---|---|
| Receipt number | R000046614 |
| Scientific Title | Transitional vertebrae in the thoracolumbar and lumbosacral regions |
| Date of disclosure of the study information | 2021/07/19 |
| Last modified on | 2021/07/17 21:52:09 |
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Basic information
Public title
Abnormalities of vertebrae in the thoracic, lumbar and sacral vertebrae
Acronym
Abnormalities of vertebrae in the thoracic, lumbar and sacral vertebrae
Scientific Title
Transitional vertebrae in the thoracolumbar and lumbosacral regions
Scientific Title:Acronym
Transitional vertebrae in the thoracolumbar and lumbosacral regions
Region
| Japan |
Condition
Condition
Lumbar degenerative disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to increase the awareness of TLTV and LSTV to reduce wrong-site surgery or diagnostic errors. Detailed knowledge of these transitional vertebrae may potentially benefit spine surgeons as well as radiologists and interventional pain medicine specialists.
Basic objectives2
Others
Basic objectives -Others
The presence of transitional vertebra in the thoracolumbar and/or lumbosacral regions may cause wrong-site surgery and problems while measuring spinopelvic parameters, including pelvic incidence and lumbar lordosis. The Castellvi classification of lumbosacral transitional vertebra (LSTV) addresses coronal images but not sagittal or axial images. Therefore, it is unclear how LSTV differs from the normal lumbosacral anatomy. We aimed to investigate the lumbosacral anatomy and vertebral numbering in patients with thoracolumbar transitional vertebrae (TLTV) and/or LSTV by performing computed tomography (CT) to identify TLTVs, to number presacral vertebrae accurately and to analyze morphological differences in each LSTV type.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Each LSTV type was examined to identify its morphological features on sagittal and axial CT images.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent spinopelvic fixation
Key exclusion criteria
None
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Tatara |
Organization
Yokohama Minami Kyosai Hospital
Division name
Spine center
Zip code
236-0037
Address
1-21-1, Mutsurahigashi, Kanazawa-ku, Yokohama
TEL
045-782-2101
yata20101107@gmail.com
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Takahashi |
Organization
Yokohama Minami Kyosai Hospital
Division name
Clinical Research Center
Zip code
236-0037
Address
1-21-1, Mutsurahigashi, Kanazawa-ku, Yokohama
TEL
045-782-2101
Homepage URL
yata20101107@gmail.com
Sponsor or person
Institute
Yokohama Minami Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama Minami Kyosai Hospital
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
Yokohama Minami Kyosai Hospital
Address
1-21-1, Mutsurahigashi, Kanazawa-ku, Yokohama
Tel
045-782-2101
https://www.minamikyousai.jp/service/rinsyou.html
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 | 07 | Month | 19 | Day |
Related information
URL releasing protocol
https://journals.lww.com/jbjsoa/Fulltext/2021/09000/Changes_in_Lumbosacral_Anatomy_and_Vertebral.4.a
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/jbjsoa/Fulltext/2021/09000/Changes_in_Lumbosacral_Anatomy_and_Vertebral.4.a
Number of participants that the trial has enrolled
124
Results
LSTVs were observed in 111/880 patients (12.6%). Castellvi type III LSTVs were the most common (42/111, 37.8%), followed by S6 LSTVs (37/111, 33.3%). TLTVs were associated with LSTVs (87/111, 78.4%) and commonly identified at T13 (59/87, 67.8%).
Results date posted
| 2020 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 07 | Month | 15 | Day |
Baseline Characteristics
Degenerative lumbar diseases who underwent thoracolumbar fusion.
Participant flow
The medical records of 880 patients who underwent thoracolumbar fusion between July 2014 and March 2020 were evaluated for TLTV and LSTV. In this study, 124 (14.1%) of 880 patients had transitional vertebrae and/or vertebral numeric variation, with a mean age (and standard deviation) of 69.7 (12.0) years and male patients accounting for 60.5% of these 124 patients.
Adverse events
None
Outcome measures
The anatomical location of the lowest thoracic vertebra was defined, and TLTV with dysplastic ribs was identified and classified. Each LSTV type was examined for its morphological features on sagittal and axial CT images.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
124 patients (14.1%) were included in this study, with a mean age of 69.7 (SD 12.0) years and male patients accounting for 60.5% of the total sample.
Management information
Registered date
| 2021 | Year | 07 | Month | 17 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046614
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