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IRCT20120527009878N5 IRCT 2019-01-03 Tabriz University of Medical Sciences Evaluation of neurological and radiological results of posterior instrumentation with and without distraction for thoracolumbar fractures Evaluation the neurological and radiological results of posterior instrumentation with and without distraction for thoracolumbar fractures 2019-03-21 anticipated 60 Complete https://irct.ir/trial/35671 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: Accordingly, the study will be triple blinded and, after analysis, will be asked from the head nurse to clarify the codes. N/A traumatic thoracolumbar fractures Because of its traumatic nature, it is not one of the pathological diseases and fractures. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Firouz Salehpour
Emam Reza hospital, Golgasht ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3335 2073 salehpourf@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Peyman Gholipoor
Emam Reza hospital, Golgasht ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 33352073 gholipoorpeyman5892@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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. 16 years 65 years Both 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 Treatment - Surgery Treatment - Surgery 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. 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. 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. 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. 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. Tabriz medicine university Approved 2018-10-07 Ethics committee of tabriz University of Medical Sciences Emam Reza hospital, Golgasht ave. Tabriz East Azarbaijan Iran (Islamic Republic of)