UMIN-CTR Clinical Trial

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
Email	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
Email	yata20101107@gmail.com

Sponsor
Institute	Yokohama Minami Kyosai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046614