- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Fawzy Ahmed Nafady, master
- Phone Number: +201555912628 +201092142188
- Email: ahmed.17289890@med.aun.edu.eg
Study Locations
-
-
Abnoub
-
Asyut, Abnoub, Egypt, 71641
- Assuit university hospitals
-
Contact:
- Khaled Mohamed Hasan Ali, MD
- Phone Number: +201005363318
- Email: khaled.ali1@med.au.edu.eg
-
Contact:
- Amr Hatem Ahmed Mohamed, MD
- Phone Number: +201027021317
- Email: amrhatemhassan@aun.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• Maintenance of correction
Time Frame: baseline
|
• Maintenance of correction (change in cobb angle from immediate postoperative to final follow-up at 12 months)
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operative kyphosis correction
Time Frame: Baseline
|
Operative kyphosis correction (change in cobb angle from preoperative to immediate postoperative)
|
Baseline
|
|
• Anterior vertebral body height ratio restoration
Time Frame: from pre operative to last follow up at 12 months
|
from pre operative to last follow up at 12 months
|
|
|
VAS
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Thoracolumber fracture
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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