Thoracolumbar Compression FracturesNCT07777653
Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study
A study testing Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study in people with Thoracolumbar Compression Fractures, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracolumbar Compression Fractures
- What is being tested?
- Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Acute traumatic thoracolumbar fracture (AO type B)
- Single-level fracture
- Neurologically intact patient (ASIA E)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed Fawzy Ahmed Nafady, master contact
Egypt1 site
Assuit University Hospitals
Asyut, Abnoub, 71641
Khaled Mohamed Hasan Ali, MD, +201005363318, khaled.ali1@med.au.edu.eg
Amr Hatem Ahmed Mohamed, MD, +201027021317, amrhatemhassan@aun.edu.eg
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Thoracolumbar Compression Fractures
- Being tested
- Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative StudyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Short Segment Transpedicular Screw Fixation in AO-Type B Thoracolumbar Fracture Alignment | Other | Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study Receives: Procedure: Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study |
| Long Segment Transpedicular Screw Fixation in Thoracolumbar Fracture Alignment | Experimental | Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study Receives: Procedure: Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Maintenance of correction
- Maintenance of correction (change in cobb angle from immediate postoperative to final follow-up at 12 months)
Measured: baseline
Secondary outcomes (4)
Operative kyphosis correction
Operative kyphosis correction (change in cobb angle from preoperative to immediate postoperative)
Measured: Baseline
• Anterior vertebral body height ratio restoration
Measured: from pre operative to last follow up at 12 months
VAS
VAS pain scores at all time points
Measured: pre operative, post operative, at 3, 6 and 12 months follow-up
ODI
ODI functional outcome scores at all time points
Measured: pre operative, post operative and at 3, 6 and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thoracolumbar Compression FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Fawzy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777653
- Sponsor's protocol ID
- Thoracolumber fracture
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32435570Al 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.
PubMed 36825073
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07777653
- Acronym / sponsor ID
- Thoracolumber fracture
- Conditions
- Thoracolumbar Compression Fractures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Segment Transpedicular Screw Fixation in AO-Type B Thoracolumbar Fracture Alignment | Other | Procedure: Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative StudyShort Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study |
| Long Segment Transpedicular Screw Fixation in Thoracolumbar Fracture Alignment | Experimental | Procedure: Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative StudyShort Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Acute traumatic thoracolumbar fracture (AO type B)
- Single-level fracture
- Neurologically intact patient (ASIA E)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative StudyThoracolumbar 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 | Procedure or surgery | Long Segment Transpedicular Screw Fixation in Thoracolumbar Fracture Alignment, Short Segment Transpedicular Screw Fixation in AO-Type B Thoracolumbar Fracture Alignment |
Primary outcome
• Maintenance of correction
Time frame: baseline
• Maintenance of correction (change in cobb angle from immediate postoperative to final follow-up at 12 months)
4 secondary outcomes
Operative kyphosis correction
Time frame: Baseline
• Anterior vertebral body height ratio restoration
Time frame: 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
ODI
Time frame: pre operative, post operative and at 3, 6 and 12 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 32435570Stam 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.
- Background: PubMed 36825073Al 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.
- Related InfoLink provided by the sponsor.
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Fawzy Ahmed Nafady, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Segment Versus Long Segment Transpedicular Screw Fixation in the Correction and Preservation of AO-Type B Thoracolumbar Fracture Alignment: A Comparative Study in people with Thoracolumbar Compression Fractures, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Fawzy Ahmed Nafady, master (+201092142188 ext. +201555912628, ahmed.17289890@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Maintenance of correction (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07777653, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.