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
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
Design
A open-label, randomized clinical trial study with parallel groups and phases 3 on 50 patients. Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
An open-label , randomized clinical trial study with parallel groups and phases 3 on 50 patients. Randomization will be done with the block randomization method using Random allocation software.
Participants/Inclusion and exclusion criteria
In this study, 50 patients ≥18 years presenting with an acute traumatic thoracolumbar burst fracture (AO type A3 or A4) within five days of injury, without neurological deficit will be included.
Exclusion criteria will be fractures due to cancer, severe osteoporosis, thyroid disorders, a Glasgow Coma Scale score of less than 15 at admission and the presence of any pre-existing spinal pathology.
Intervention groups
Patients in intervention group undergoing a combined procedure consisting of transpedicular balloon kyphoplasty followed by short-segment posterior instrumentation. Patients in control group undergoing conventional short-segment posterior instrumentation using a pedicle screw–rod system.
Main outcome variables
This open-label randomised clinical trial will be conducted on patients with an acute traumatic thoracolumbar burst fracture who referring to Urmia Imam Khomeini Hospital. Patients will be assigned into conventional Short-segment pedicle screw instrumentation with and without balloon kyphoplasty.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230520058233N3
Registration date:2026-04-29, 1405/02/09
Registration timing:prospective
Last update:2026-04-29, 1405/02/09
Update count:0
Registration date
2026-04-29, 1405/02/09
Registrant information
Name
Peyman Gholipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
gholipour.p@umsu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-09-22, 1405/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the posterior-fusion instrumentation with and without balloon kyphoplasty on the radiological res
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Khomeini Hospital, Urmia University of Medical Science
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.
Category
Treatment - Surgery
2
Description
Control group: Patients in this group undergoing conventional short-segment posterior instrumentation using a pedicle screw–rod system.