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IRCT20200615047777N1 IRCT 2020-06-17 Tabriz University of Medical Sciences Investigating two modes of traction and non-traction use of the vertebrae in the postoperative instrumentation method in patients with traumatic fractures of the lumbar-thoracic vertebrae in radiological results and improvement in neurological symptoms Evaluation of neurological and Radiological results of Posterior instrumentation with and without Distraction for thoracolumbar fractures 2020-07-11 anticipated 60 Complete https://irct.ir/trial/48922 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization of the study will be as follows by software R version 3.2, 60 random sequences A and B that have 30 modes A and 30 modes B and their labels will be prepared, which is one of the cases related to the surgical method with It will be stretching and will be one of the cases related to the surgical method without stretching, Blinding description: The researcher or patient will not be aware of the type of surgery method, but the head of the trauma department of Imam Reza Hospital in Tabriz and the operating room staff will be aware of this and will stick one of the A or B stickers in the patient's file and after transferring the patient to the room. The operation will be performed by observing one of the two cases according to the relevant default (which the operating room staff is aware of). Knowing which surgery method was chosen will examine the patient neurologically and will record radiological criteria for the patient. The statistical analyzer is also unaware of the type of surgical procedure performed, and based on this, the study will be blinded three times. After the analysis, the head of type A and B methods will be asked. 3 Traumatic fractures of the thoracolumbar vertebrae. Intervention 1: Intervention group: Patients who undergo stretching after screwing and then fixation. Intervention 2: Control group:Patients who undergo screwing without fixation. 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 There is no more information
public Dr. Moslem Shakeri
Emam Reza Hospital, Gholghasht Street, Azadi Street,
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 shakerim@gmail.com Tabriz University of Medical Sciences scientific Dr. Moslem Shakeri
Emam Reza Hospital, Gholghasht Street, Azadi Stree
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 shakerim@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Spinal fractures due to the type of fracture - a fracture that will be diagnosed based on the three-column model of Denis in the CT Scan and attention to the damaged columns, which will be interpreted by the neurosurgery resident. Having an indication for surgery, which is an indication of decision making for surgery based on the Thoracolumbar injury classification severity score (TLCS) scoring system. In short, it includes three independent factors or computed tomography scans and MRI findings and findings related to neurological examination. Having a conscious consent to participate in the study 16 years 70 years Both Having pathological fractures Fracture in several vertebrae The trauma of the head at the same time and the neurological condition of the patient should be such that it is not possible to - Having a nervous defect before spinal trauma Shear fracture is a type of fracture Treatment - Surgery Treatment - Surgery Intervention group: Patients who undergo stretching after screwing and then fixation Control group:Patients who undergo screwing without fixation Anterior vertebral height. Timepoint: Upon arrival and during discharge and 3 months later. Method of measurement: Using a ruler in millimeters. Percentage of anterior vertebral collapse. Timepoint: Upon arrival and during discharge and 3 months later. Method of measurement: in term of percentage. The posterior height of the vertebra is broken. Timepoint: Upon arrival and during discharge and 3 months later. Method of measurement: Using a ruler and in millimeters. Percentage of posterior vertebral collapse. Timepoint: Upon arrival and during discharge and 3 months later. Method of measurement: in term of percentage. Local kyphosis angle. Timepoint: Upon arrival and during discharge and 3 months later. Method of measurement: Using conveyor and by degree. Nervous symptoms. Timepoint: Upon arrival and during discharge and 3 months later. Method of measurement: According to the Frankel scale, the division into 5 groups of A - E. Type of surgical method. Timepoint: Upon arrival and during discharge and 3 months later. Method of measurement: According to the division into A and B. Year. Timepoint: Upon arrival and during discharge and 3 months later. Method of measurement: depending on year. Gender. Timepoint: Upon arrival and during discharge and 3 months later. Method of measurement: Depending on the gender of the man or woman. Tabriz University of Medical Sciences Approved 2018-10-08 Ethics Committee of Tabriz Medical School Golgasht Street / Tabriz University of Medical Sciences / Central Building No. 2 / Third Floor Tabriz East Azarbaijan Iran (Islamic Republic of)