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IRCT20230520058233N3 IRCT 2026-04-29 Oroumia University of Medical Sciences Investigating the posterior-fusion instrumentation with and without balloon kyphoplasty on the radiological res Comparison of posterior-fusion instrumentation with and without balloon kyphoplasty and polymethyl methacrylate cement injection on the radiological results of traumatic fractures of thoraco-lumbar vertebrae 2026-05-22 anticipated 50 Recruiting https://irct.ir/trial/89092 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Patients will be divided into intervention and control groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated in intervention or control groups based on generated numbers. 3 Acute traumatic thoracolumbar fractures. Intervention 1: Intervention group: Patients in this group undergoing a combined procedure consisting of transpedicular balloon kyphoplasty followed by short-segment posterior instrumentation.First Balloon kyphoplasty wI'll be performed at the level of the fractured vertebra. After standard preparation, inflatable bone tamps will inserted via a transpedicular approach and gradually inflated under fluoroscopic guidance to restore endplate height and create an intravertebral cavity. The cavity will subsequently filled with polymethylmethacrylate (PMMA) cement under continuous fluoroscopic monitoring.Following cement augmentation, short-segment posterior instrumentation will performed using a pedicle screw–rod system. Intervention 2: Control group: Patients in this group undergoing conventional short-segment posterior instrumentation using a pedicle screw–rod system. No - There is not a plan to make this available Justification or reason for not sharing IPD is There are no additional information
public Dr. Peyman Gholipour
Imam Khomeini hospital., Ershad Ave., Modarress Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 098 44 33457286 gholipour.p@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Peyman Gholipour
Imam Khomeini hospital., Ershad Ave., Modarress Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 gholipour.p@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Adult patients over 18 years Patients with an acute traumatic thoracolumbar burst fracture (AO type A3 or A4) Patients who referring within five days of injury without neurological deficit 18 years no limit Both Patients with fractures due to cancer and severe osteoporosis Thyroid disorders Glasgow Coma Scale score of less than 15 at admission The presence of any pre-existing spinal pathology Treatment - Surgery Treatment - Surgery Intervention group: Patients in this group undergoing a combined procedure consisting of transpedicular balloon kyphoplasty followed by short-segment posterior instrumentation.First Balloon kyphoplasty wI'll be performed at the level of the fractured vertebra. After standard preparation, inflatable bone tamps will inserted via a transpedicular approach and gradually inflated under fluoroscopic guidance to restore endplate height and create an intravertebral cavity. The cavity will subsequently filled with polymethylmethacrylate (PMMA) cement under continuous fluoroscopic monitoring.Following cement augmentation, short-segment posterior instrumentation will performed using a pedicle screw–rod system. Control group: Patients in this group undergoing conventional short-segment posterior instrumentation using a pedicle screw–rod system. Cobb angle. Timepoint: Before and one year after intervention. Method of measurement: Radio graphy. Anterior vertebral body height (ABH. Timepoint: Before and one year after intervention. Method of measurement: Radio graphy. Posterior vertebral body height (PBH). Timepoint: Before and one year after intervention. Method of measurement: Radio graphy. Infection of site surgery. Timepoint: One year after intervention. Method of measurement: Clinical examination. Oroumia University of Medical Sciences Approved 2024-07-10 Ethics Committee of Imam Khomeini Khomeini Hospital, Urmia University of Medical Science Imam Khomeini hospital., Ershad Ave., Modarress Blvd., Urmia., Iran. Urmia West Azarbaijan Iran (Islamic Republic of)