- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07777653
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ahmed Fawzy Ahmed Nafady, master
- Telefonnummer: +201555912628 +201092142188
- E-mail: ahmed.17289890@med.aun.edu.eg
Studiesteder
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Abnoub
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Asyut, Abnoub, Egypten, 71641
- Assuit university hospitals
-
Kontakt:
- Khaled Mohamed Hasan Ali, MD
- Telefonnummer: +201005363318
- E-mail: khaled.ali1@med.au.edu.eg
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Kontakt:
- Amr Hatem Ahmed Mohamed, MD
- Telefonnummer: +201027021317
- E-mail: amrhatemhassan@aun.edu.eg
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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 |
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
• Maintenance of correction
Tidsramme: baseline
|
• Maintenance of correction (change in cobb angle from immediate postoperative to final follow-up at 12 months)
|
baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Operative kyphosis correction
Tidsramme: Baseline
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Operative kyphosis correction (change in cobb angle from preoperative to immediate postoperative)
|
Baseline
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• Anterior vertebral body height ratio restoration
Tidsramme: from pre operative to last follow up at 12 months
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from pre operative to last follow up at 12 months
|
|
|
VAS
Tidsramme: pre operative, post operative, at 3, 6 and 12 months follow-up
|
VAS pain scores at all time points
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pre operative, post operative, at 3, 6 and 12 months follow-up
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ODI
Tidsramme: pre operative, post operative and at 3, 6 and 12 months follow up
|
ODI functional outcome scores at all time points
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pre operative, post operative and at 3, 6 and 12 months follow up
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Thoracolumber fracture
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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