UMIN-CTR Clinical Trial

Basic information
Public title	Segmental artery injury and/or massive haemothorax due solely to spinal fractures
Acronym	Segmental artery injury and/or massive haemothorax due solely to spinal fractures
Scientific Title	Segmental artery injury and/or massive haemothorax due solely to spinal fractures
Scientific Title:Acronym	Segmental artery injury and/or massive haemothorax due solely to spinal fractures
Region	Japan

Condition
Condition	Lumbar and thoracic spinal fracture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the incidence and features in diagnosis and treatment of segmental artery injury and massive hemothorax due solely to spinal fractures.
Basic objectives2	Others
Basic objectives -Others	To let traumatologists and orthopedic surgeons know this pathology.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	age, sex, incidence, injury severity score, levels of spinal fractures, type of fracture, presence or absence of DISH, neurological findings, treatment, and results
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Segmental artery injury and massive hemothorax due solely to thoracolumbar spinal fractures
Key exclusion criteria	segmental artery injury or massive hemothorax due to thoracic injury in multiple trauma patients
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Masanari Middle name Last name Takami
Organization	Wakayama Medical University
Division name	Orthopaedic surgery
Zip code	6418510
Address	811-1 Kimiidera, Wakayama
TEL	0734410645
Email	takami@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Masanari Middle name Last name Takami
Organization	Wakayama Medical University
Division name	Orthopaedic surgery
Zip code	6418510
Address	811-1 Kimiidera, Wakayama
TEL	0734410645
Homepage URL
Email	takami@wakayama-med.ac.jp

Sponsor
Institute	Dept. of Orthop. Surg., Wakayama Medical Univ.
Institute
Department

Funding Source
Organization	Dept. of Orthop. Surg., Wakayama Medical Univ.
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	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama
Tel	0734472300
Email	wa-rinri@wakayama-med.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	2020 Year 06 Month 10 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	202
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	Completed
Date of protocol fixation	2020 Year 03 Month 11 Day
Date of IRB	2020 Year 03 Month 11 Day
Anticipated trial start date	2020 Year 03 Month 11 Day
Last follow-up date	2025 Year 03 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

From January 2009 to December 2019, 202 consecutive cases of emergency transfer to our hospital diagnosed with thoracic fracture were investigated. For patients with segmental artery injury and massive hemothorax due to thoracic fracture, the survey items were incidence, mechanism of injury, level of spinal fracture, fracture type, neurological symptoms, presence of diffuse idiopathic skeletal hyperostosis (DISH), treatment method, and outcome were investigated.

Management information
Registered date	2020 Year 06 Month 10 Day
Last modified on	2022 Year 06 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046467