Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study
Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study. To Compare the Radiological, Clinical and Functional Outcomes of Short-segment Versus Long-segment Transpediclular Screw Fixation in Patients With Thoracolumbar Fractures AO-type B.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Thoracolumbar fractures represent the most common spinal injuries, predominantly occurring at the T11-L2 junction due to the biomechanical transition from the rigid thoracic to the mobile lumbar spine. This region accounts for approximately half of all traumatic spinal fractures, owing to changes in spinal curvature, facet joint orientation, and load-bearing mechanics (1).
Surgical management aims to restore spinal stability, correct kyphotic deformity, decompress neural elements, and enable early mobilization. Two posterior fixation strategies exist: short-segment fixation (SSF), spanning one level above and below the fracture with one or 2 intermediate screws in the fractured vertebra itself, and long-segment fixation (LSF), spanning two or more levels above and below with one or 2 intermediate screws in the fractured vertebra itself. Short-segment constructs preserve more motion segments with reduced surgical morbidity, while long-segment constructs provide potentially greater stability (2).
The optimal choice remains debated. A 2025 meta-analysis of 17 trials (1,031 patients) showed that LSF was associated with higher blood loss and longer operative time but better kyphosis correction maintenance and pain improvement (3). Short-segment fixation with intermediate screws at the fracture level has shown comparable results to LSF while preserving motion segments and reducing costs (4).
There is no randomized trial on AO-type B. Given these controversies, a prospective comparative study in our population is warranted.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahmed Fawzy Ahmed Nafady, master
- Número de teléfono: +201555912628 +201092142188
- Correo electrónico: ahmed.17289890@med.aun.edu.eg
Ubicaciones de estudio
-
-
Abnoub
-
Asyut, Abnoub, Egipto, 71641
- Assuit university hospitals
-
Contacto:
- Khaled Mohamed Hasan Ali, MD
- Número de teléfono: +201005363318
- Correo electrónico: khaled.ali1@med.au.edu.eg
-
Contacto:
- Amr Hatem Ahmed Mohamed, MD
- Número de teléfono: +201027021317
- Correo electrónico: amrhatemhassan@aun.edu.eg
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18-65 years
- Acute traumatic thoracolumbar fracture (AO type B)
- Single-level fracture
- Neurologically intact patient (ASIA E)
Exclusion Criteria:
- Pathological fractures (malignancy, infection, metabolic bone disease)
- Significant neurological deficit (ASIA A-D)
- Previous spinal surgery at or adjacent to the fracture level
- 2 or more level fractures
- Associated anterior column reconstruction requirement (corpectomy)
- Polytrauma precluding early spinal surgery
- Pregnancy
- Performance of surgical decompression
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Short Segment Transpedicular Screw Fixation in AO-Type B Thoracolumbar Fracture Alignment
Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study
|
Thoracolumbar fractures represent the most common spinal injuries, predominantly occurring at the T11-L2 junction due to the biomechanical transition from the rigid thoracic to the mobile lumbar spine. This region accounts for approximately half of all traumatic spinal fractures, owing to changes in spinal curvature, facet joint orientation, and load-bearing mechanics (1). Surgical management aims to restore spinal stability, correct kyphotic deformity, decompress neural elements, and enable early mobilization. Two posterior fixation strategies exist: short-segment fixation (SSF), spanning one level above and below the fracture with one or 2 intermediate screws in the fractured vertebra itself, and long-segment fixation (LSF), spanning two or more levels above and below with one or 2 intermediate screws in the fractured vertebra itself. Short-segment constructs preserve more motion segments with reduced surgical morbidity, while long-segment constructs provide potentially greater stabi |
|
Experimental: Long Segment Transpedicular Screw Fixation in Thoracolumbar Fracture Alignment
Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study
|
Thoracolumbar fractures represent the most common spinal injuries, predominantly occurring at the T11-L2 junction due to the biomechanical transition from the rigid thoracic to the mobile lumbar spine. This region accounts for approximately half of all traumatic spinal fractures, owing to changes in spinal curvature, facet joint orientation, and load-bearing mechanics (1). Surgical management aims to restore spinal stability, correct kyphotic deformity, decompress neural elements, and enable early mobilization. Two posterior fixation strategies exist: short-segment fixation (SSF), spanning one level above and below the fracture with one or 2 intermediate screws in the fractured vertebra itself, and long-segment fixation (LSF), spanning two or more levels above and below with one or 2 intermediate screws in the fractured vertebra itself. Short-segment constructs preserve more motion segments with reduced surgical morbidity, while long-segment constructs provide potentially greater stabi |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
• Maintenance of correction
Periodo de tiempo: baseline
|
• Maintenance of correction (change in cobb angle from immediate postoperative to final follow-up at 12 months)
|
baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Operative kyphosis correction
Periodo de tiempo: Baseline
|
Operative kyphosis correction (change in cobb angle from preoperative to immediate postoperative)
|
Baseline
|
|
• Anterior vertebral body height ratio restoration
Periodo de tiempo: from pre operative to last follow up at 12 months
|
from pre operative to last follow up at 12 months
|
|
|
VAS
Periodo de tiempo: pre operative, post operative, at 3, 6 and 12 months follow-up
|
VAS pain scores at all time points
|
pre operative, post operative, at 3, 6 and 12 months follow-up
|
|
ODI
Periodo de tiempo: pre operative, post operative and at 3, 6 and 12 months follow up
|
ODI functional outcome scores at all time points
|
pre operative, post operative and at 3, 6 and 12 months follow up
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Stam WT, Deunk J, Elzinga MJ, Bloemers FW, Giannakopoulos GF. The Predictive Value of the Load Sharing Classification Concerning Sagittal Collapse and Posterior Instrumentation Failure: A Systematic Literature Review. Global Spine J. 2020 Jun;10(4):486-492. doi: 10.1177/2192568219856581. Epub 2019 Jun 16.
- Al Mamun Choudhury A, Alam MS, Jonayed S, Dastagir O, Jahan MS. Long-Segment Versus Short-Segment Pedicle Screw Fixation Including Fractured Vertebrae for the Management of Unstable Thoracolumbar Burst Fractures. Cureus. 2023 Feb 20;15(2):e35235. doi: 10.7759/cureus.35235. eCollection 2023 Feb.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Thoracolumber fracture
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .