- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ahmed Fawzy Ahmed Nafady, master
- Numer telefonu: +201555912628 +201092142188
- E-mail: ahmed.17289890@med.aun.edu.eg
Lokalizacje studiów
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Abnoub
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Asyut, Abnoub, Egipt, 71641
- Assuit university hospitals
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Kontakt:
- Khaled Mohamed Hasan Ali, MD
- Numer telefonu: +201005363318
- E-mail: khaled.ali1@med.au.edu.eg
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Kontakt:
- Amr Hatem Ahmed Mohamed, MD
- Numer telefonu: +201027021317
- E-mail: amrhatemhassan@aun.edu.eg
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Inny: 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 |
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Eksperymentalny: 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 |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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• Maintenance of correction
Ramy czasowe: baseline
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• Maintenance of correction (change in cobb angle from immediate postoperative to final follow-up at 12 months)
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baseline
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Operative kyphosis correction
Ramy czasowe: Baseline
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Operative kyphosis correction (change in cobb angle from preoperative to immediate postoperative)
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Baseline
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• Anterior vertebral body height ratio restoration
Ramy czasowe: from pre operative to last follow up at 12 months
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from pre operative to last follow up at 12 months
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VAS
Ramy czasowe: pre operative, post operative, at 3, 6 and 12 months follow-up
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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
Ramy czasowe: pre operative, post operative and at 3, 6 and 12 months follow up
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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
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- Thoracolumber fracture
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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