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IRCT20120527009878N3 IRCT 2018-09-13 Tabriz University of Medical Sciences The effect of using interface between right and left screws on bone formation around broken vertebrae Evaluation of the effect of Cross-linkage between pedicular screws for fusion in patient with traumatic thoracolumbar vertebral fractures 2017-07-23 anticipated 60 Complete https://irct.ir/trial/33278 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients undergoing surgery will be divided into three random groups using the www.random.org by the Gaussian Generator order, Blinding description: After random assignment of the study groups, the A, B and C labels were assigned to the target group by the secretary. Then, the patients will be intervened by the researcher in the operating room in the case group. All persons involved in the study will be unaware of the type of intervention performed. 3 Traumatic thoracolumbar vertebral fractures. Intervention 1: Control group (A): After the patient's preparation, fixation and posterior fusion will be done using a pedicure screw and the rod will inserted. Then the fusion will be effected by the otograft, which is obtained from the spinous process and the lamina of the vertebrae, and at this stage the action will be terminated. Intervention 2: Intervention group (B): After preparing the patient, fixation and posterior fusion are completed using a pedicle and after the installation of the Rod, the fusion will be effected by the otograft, which is obtained from the spinous process and the lamina of the vertebrae. Then a cross link is placed in the central part of the structure and the instrumentation process will end. Intervention 3: Intervention group (C): After the patient's preparation, fixation and posterior fusion will be done using a pedicure screw. After the rod is inserted, the fusion will be effected by otograft, which is obtained from the spinous process and the lamina of the vertebrae. Then, two cross-links, one at the lower end and one at the upper end of the structure, will be completed and the instrumentation process will be completed. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Access will be 6 months after the results are printed. To whom: All Physicians and residents of the department of neurosurgery Conditions: After obtaining permission from the deputy research group Where to obtain: Person responsible for scientific accountability study How to obtain: First approved by the Research Vice-President Comments:
public Dr. Ghaddar Shokuhi Tabrizi
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1334 0830 salehpourf@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Firoz Salehpoor
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1334 0830 salehpourf@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Traumatic fractures of type of compression, sprain and fracture due to spinal flexure Thoracolumbar Injury Classification and Severity Score (TILCS) more than 4 Completing the informed consent form no limit no limit Both Traumatic fractures of type of fracture-in-depression Pathological fractures Fracture in several vertebrae Head trauma simultaneous with vertebral fracture A neurological condition in which neurological examination is not possible for the patient at the time of admission Having a nerve defect before the spinal trauma S32.0 Fracture of lumbar vertebra Treatment - Surgery Treatment - Surgery Treatment - Surgery Control group (A): After the patient's preparation, fixation and posterior fusion will be done using a pedicure screw and the rod will inserted. Then the fusion will be effected by the otograft, which is obtained from the spinous process and the lamina of the vertebrae, and at this stage the action will be terminated. Intervention group (B): After preparing the patient, fixation and posterior fusion are completed using a pedicle and after the installation of the Rod, the fusion will be effected by the otograft, which is obtained from the spinous process and the lamina of the vertebrae. Then a cross link is placed in the central part of the structure and the instrumentation process will end. Intervention group (C): After the patient's preparation, fixation and posterior fusion will be done using a pedicure screw. After the rod is inserted, the fusion will be effected by otograft, which is obtained from the spinous process and the lamina of the vertebrae. Then, two cross-links, one at the lower end and one at the upper end of the structure, will be completed and the instrumentation process will be completed. Lumbar vertebral fusion. Timepoint: At the beginning of the study, 6 months after the intervention. Method of measurement: Using radiological evaluations and physical examination using visual analogue scale. Tabriz University of Medical Sciences Approved 2018-08-06 Tabriz University of Medical Science Tabriz University of Medical Science , Gholghasht street , Azadi street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)