Evaluation of neurological and Radiological results of Posterior instrumentation with and without Distraction for thoracolumbar fractures
Design
This triple-blind study was performed on patients with thoracolumbar fractures in the control group at the end of the operation without distraction force fixation will done, but in the trail group before fixation, the distraction force will be applied to the screws and then fixation will be done.
Settings and conduct
This study will be randomized clinical trial study on 60 patients with thoracolumbar vertebral fractures due to spinal cord trauma who refer to Imam Reza Hospital in Tabriz. Patients participating in the study will be done posterior fusionwith pedicure screw. then patients is divided into two groups, A or B, which have already been identified. The patient will not be aware of the type of surgery method, but the head nurse 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 operating room. One of the two modes of observation will be performed according to the relevant default (which the operating room staff is aware of).
Participants/Inclusion and exclusion criteria
1- Spinal fractures due to the type of fracture
2- Having indications for surgery
Criteria for leaving the study:
1- Having pathological fractures
2- Fracture in several vertebrae
3- Simultaneous head trauma
Intervention groups
trail group: Patients who undergo stretching after screwing and then fixation
Control group: After screwing, you apply without applying fixation
Evaluation of neurological and Radiological results of Posterior instrumentation with and without Distraction for thoracolumbar fractures
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 16 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical School
Street address
Golgasht Street / Tabriz University of Medical Sciences / Central Building No. 2 / Third Floor
City
Tabriz
Province
East Azarbaijan
Postal code
04133357310
Approval date
2018-10-08, 1397/07/16
Ethics committee reference number
IR.TBZMED.REC.1397.596
Health conditions studied
1
Description of health condition studied
Traumatic fractures of the thoracolumbar vertebrae
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
anterior vertebral height
Timepoint
Upon arrival and during discharge and 3 months later
Method of measurement
Using a ruler in millimeters
2
Description
Percentage of anterior vertebral collapse
Timepoint
Upon arrival and during discharge and 3 months later
Method of measurement
in term of percentage
3
Description
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
4
Description
Percentage of posterior vertebral collapse
Timepoint
Upon arrival and during discharge and 3 months later
Method of measurement
in term of percentage
5
Description
Local kyphosis angle
Timepoint
Upon arrival and during discharge and 3 months later
Method of measurement
Using conveyor and by degree
6
Description
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
7
Description
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.
8
Description
year
Timepoint
Upon arrival and during discharge and 3 months later
Method of measurement
depending on year
9
Description
Gender
Timepoint
Upon arrival and during discharge and 3 months later
Method of measurement
Depending on the gender of the man or woman
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who undergo stretching after screwing and then fixation
Category
Treatment - Surgery
2
Description
Control group:Patients who undergo screwing without fixation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Ward of Emem Reza hospital
Full name of responsible person
peyman gholipor
Street address
Azadi St. Golghast St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
gholipoorpeyman5892@gmail.com
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
Golghast Street ...Azadi St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 3176
Email
Meshkinia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?