Comparison of neurological and radiological results of posterior instrumentation with and without distraction for thoracolumbar fractures
Design
This study was conducted in a randomized clinical trial on 60 patients with thoracolumbar vertebral fracture resulting from spinal column trauma referring to Imam Reza Hospital in Tabriz.
Settings and conduct
This study will be carried out at Tabriz Imam Reza Hospital in the form of a triple -blind, only the head nurse will be aware of it, and the patient and the patient will be unaware of it.
Participants/Inclusion and exclusion criteria
Spinal cord sprain is due to the type of fracture; dislocation; signing informed consent to participate in the study
Intervention groups
This study was conducted as an interventional study on patients with traumatic lumbar-bone fractures referred to Imam Reza Emergency Hospital in Tabriz and the criteria for entering the study. For this purpose and according to previous studies And according to the probable number of those referring to Emam Reza Emergency Hospital in Tabriz and the constraints on entry criteria, 60 patients with entry criteria will be selected.
Main outcome variables
neurological and radiological results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N5
Registration date:2019-01-03, 1397/10/13
Registration timing:prospective
Last update:2019-01-03, 1397/10/13
Update count:0
Registration date
2019-01-03, 1397/10/13
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the neurological and radiological results of posterior instrumentation with and without distraction for thoracolumbar fractures
Public title
Evaluation of neurological and radiological results of posterior instrumentation with and without distraction for thoracolumbar fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with traumatic thoracolumbar fractures referring to emergency department of Imam Reza Hospital in Tabriz and undergoing surgery
Have informed consent to participate in the study
Indication for surgical determination that determines the surgical decision based on the Thoracolumbar injury classification severity score (TLCS). According to this scoring system, if the score is more than 4, it will have a surgical indication.
Exclusion criteria:
Pathological fractures
Fractures in several bons
Simultaneous head trauma and neurological condition of the patient in such a way that it is not possible to have a neurological examination at the time of admission
Having a nerve defect before a spinal trauma
Fractures of the type of fracture - dislocation
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the study will be chosen by R software version 3.2, 60 random sequences A and B with 30 modes A and 30 B modes, and their labels will be prepared, which is one of the scenarios related to the surgical method Stretching will be one of the conditions related to the method of stretching surgery (without the researcher or patient to know) that the chief nurse of the trauma department at Tabriz Imam Hospital Hospital and the operating room staff will be aware of this and will have one of the A or B stickers It will stick to the patient's case and after passing the patient into the operating room by observing one of the two conditions according to the default one (which the operation box is aware of) The relevant animal will be performed and after the patient is discharged, a corresponding label will be affixed to the patient's case summary. Three months later the examiner, without knowing which surgical procedure was selected, examined the patient and submitted radiological records to the patient. It will be unclear whether the statistical method is of a surgical method. Accordingly, the study will be blinded three times and, after analysis, will be asked from the head nurse the method A and B will be asked.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Accordingly, the study will be triple blinded and, after analysis, will be asked from the head nurse to clarify the codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tabriz University of Medical Sciences
Street address
Emam Reza hospital, Golgasht ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2018-10-07, 1397/07/15
Ethics committee reference number
IR.TBZMED.REC.1397.596
Health conditions studied
1
Description of health condition studied
traumatic thoracolumbar fractures Because of its traumatic nature, it is not one of the pathological diseases and fractures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Radiological variable: Anterior hemorrhage of the vertebrae and anterior collapse percentage of the vertebrae
Timepoint
Before and after surgery and referral 3 months later
Method of measurement
By simple radiography, the anterior height of the nut is expressed in millimeters. In order to measure the collapse, the anterior height of the broken nut is divided by the height of the anterior vertebrae by 100 times.
2
Description
Radiographic variables: Posterior height of the broken nut and the percentage of posterior collapse of the vertebra
Timepoint
Before and after surgery and referral 3 months later
Method of measurement
By simple radiography, the posterior height of the nut is expressed in millimeters, and for measuring the collapse of the vertebra, the posterior height of the broken nut is divided by the posterior height of the normal nut by 100.
3
Description
Clinical signs that will be expressed according to Frankl's standard.
Timepoint
Before and after surgery and referral 3 months later
Method of measurement
According to Frankl's criterion, where A means a complete loss of motor function and sensation below the level of the lesion, it means complete health.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients participating in the study will be transferred to the operating room within one to two days after diagnosis and marking, and will be anesthetized and wound on the bed in the operating room, and in the middle of the longitudinal line to reach the broken nut and The upper and lower vertebrae will be opened and then the fixation and posterior fusion will be done using a pedicure screw. At this stage, the patients will be divided into two groups: intervention and control of the distraction group.
Category
Treatment - Surgery
2
Description
Control group: Patients participating in the study will be transferred to the operating room within one to two days after diagnosis and marking, and will be anesthetized and wound in the bed of the operating room, and in the middle of the longitudinal line to achieve the broken nut, and The upper and lower vertebrae will open and then the posterior fixation and fusion will be done using a pedicure screw, and in the distraction group, the rod will not be removed and will be closed without diserection.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Peyman Gholipoor
Street address
Emam Reza hospital, Golgasht ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Fax
+98 41 3335 2073
Email
shoukohi@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Golgasht ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Fax
+98 41 3335 2073
Email
shoukohi@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?