Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 FracturesNCT07192250
Thoracolumbar Burst Fracture Management: Randomized Trial
A study testing short segment TPF and conservative management in people with Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 Fractures, run by Ahmed Hamed Kassem Abdelaal at 1 site in Egypt.
Trial summary
Between December 2019 to December 2022, patients presenting to causalty department with TL fracture type A3 and A4 with a TL AOSIS scores of 4 and 5 were randomly managed either by conservative or operative management. Read more about this study
- Who is it for?
- Ages 21 to 57 years
- Conditions the study is for
- Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 Fractures
- What is being tested?
- short segment TPF and conservative management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Dec 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 57 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Skeletally mature patients (age 21-55 years old), TL spine fractures of types A3 and A4 with TL AOSIS score 4 or 5. These include different variables; A4N0, A3N1, A3N2 and A3M1N0.
Who cannot join
- Osteoporotic fractures and skeletally immature patients, associated comorbidities (e.g. bleeding disorders, rheumatoid arthritis), or any fracture type other than A3 and A4, and significant neurological compromise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Thoracolumbar AOSpine Injury Score: Clinical And Radiological Outcomes Of Management Of Fractures Having Scores Of 4 And 5: A Prospective Randomized Trial
Between December 2019 to December 2022, patients presenting to causalty department with TL fracture type A3 and A4 with a TL AOSIS scores of 4 and 5 were randomly managed either by conservative or operative management.
Read the detailed description
Conservative management group was treated by bed rest and brace for 3 weeks followed by early mobilization. Operative management group received management through Short-segment fixation with one or two screws in fractured vertebra when applicable with posterior spinal fusion. Patients were evaluated both clinically regarding pain (VAS score), disability by Oswestry Disability Index (ODI score) and neurological status. Radiological evaluation included local sagittal spinal alignment, including pre- and post- management Cobb angle and local segment kyphosis. Bony fusion was also evaluated.
- Conditions
- Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 Fractures
- Being tested
- short segment TPF, conservative management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short segment TPFProcedure or surgery
short segment transpedicular screw fixation with one or two screws in fractured vertebra
conservative managementProcedure or surgery
brace and bed rest with mobilization as tolerated
| Study group | Role | What they receive |
|---|---|---|
| operative group | Active comparator | Not described Receives: Procedure: short segment TPF |
| conservative group | Active comparator | Not described Receives: Procedure: conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
VAS score
Measured: 6 months
healing
radiological union
Measured: 6 months
deformity
Cobb angle
Measured: 1 year
Secondary outcomes (1)
function
ODI score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start23 Dec 2019
- Primary completion23 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 FracturesStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Hamed Kassem Abdelaal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Hamed Kassem Abdelaal, Sohag University
- Investigators
- mohamed younis, lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192250
- Sponsor's protocol ID
- 585/9/444
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thoracolumbar AOSpine Injury Score: Clinical And Radiological Outcomes Of Management Of Fractures Having Scores Of 4 And 5: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07192250
- Acronym / sponsor ID
- 585/9/444
- Conditions
- Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ahmed Hamed Kassem AbdelaalUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 Sep 2025 (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.
Between December 2019 to December 2022, patients presenting to causalty department with TL fracture type A3 and A4 with a TL AOSIS scores of 4 and 5 were randomly managed either by conservative or operative management.
Detailed description
Conservative management group was treated by bed rest and brace for 3 weeks followed by early mobilization. Operative management group received management through Short-segment fixation with one or two screws in fractured vertebra when applicable with posterior spinal fusion. Patients were evaluated both clinically regarding pain (VAS score), disability by Oswestry Disability Index (ODI score) and neurological status. Radiological evaluation included local sagittal spinal alignment, including pre- and post- management Cobb angle and local segment kyphosis. Bony fusion was also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| operative group | Active comparator | Procedure: short segment TPF |
| conservative group | Active comparator | Procedure: conservative management |
Who may qualify
- Ages
- 21 to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Skeletally mature patients (age 21-55 years old), TL spine fractures of types A3 and A4 with TL AOSIS score 4 or 5. These include different variables; A4N0, A3N1, A3N2 and A3M1N0.
Key exclusion criteria (1 listed)
- Osteoporotic fractures and skeletally immature patients, associated comorbidities (e.g. bleeding disorders, rheumatoid arthritis), or any fracture type other than A3 and A4, and significant neurological compromise.
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 TPFshort segment transpedicular screw fixation with one or two screws in fractured vertebra | Procedure or surgery | operative group |
| conservative managementbrace and bed rest with mobilization as tolerated | Procedure or surgery | conservative group |
Primary outcome
Pain score
Time frame: 6 months
VAS score
healing
Time frame: 6 months
radiological union
deformity
Time frame: 1 year
Cobb angle
1 secondary outcome
function
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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. This study is not recruiting at the moment.
mohamed younis, lecturer principal investigator
Sohag University
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 TPF and conservative management in people with Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 Fractures, run by Ahmed Hamed Kassem Abdelaal 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2025.