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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230520058233N3
Enrollment
50
Registered
2026-04-29
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute traumatic thoracolumbar fractures.

Interventions

Intervention 1: Intervention group: Patients in this group undergoing a combined procedure consisting of transpedicular balloon kyphoplasty followed by short-segment posterior instrumentation.First Ba

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Infection of site surgery. Timepoint: One year after intervention. Method of measurement: Clinical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Peyman Gholipour

Oroumia University of Medical Sciences

gholipour.p@umsu.ac.ir098 44 33457286

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026