Spine FractureNCT06458309
Mangement of Spine Fracture
A study testing spine surgery in people with Spine Fracture, run by Sohag University at 1 site in Egypt.
Trial summary
Each year, there are approximately 5 million new vertebral fractures worldwide1. Most of these fractures involve the thoracolumbar or lumbar spines. The thoracolumbar junction, due to its mechanical transition zone, and the lumbar spine, due to its absence of stabilizing articulations with the ribs, lordotic posture… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Spine Fracture
- What is being tested?
- spine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2024to 25 Sep 2025
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1-Skeletally mature patients (18yrs and older). 2-Thoracolumbar fractures.
Who cannot join
- 1-skeletally immature patients. 2-pathological fractures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor, 0934602963, portal@med.sohag.edu.eg
About this study
Official title: Management of Spine Fractures According to The Thoracolumbar AO Spine Injury Score
Each year, there are approximately 5 million new vertebral fractures worldwide1. Most of these fractures involve the thoracolumbar or lumbar spines. The thoracolumbar junction, due to its mechanical transition zone, and the lumbar spine, due to its absence of stabilizing articulations with the ribs, lordotic posture and more sagittal oriented facet joints, are vulnerable for involvement in spinal injuries2.
Burst fractures occurs frequently in high-energy traumas which are most commonly associated with falls and traffic accidents.3
- Conditions
- Spine Fracture
- Being tested
- spine surgery
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spine surgeryProcedure or surgery
AO Classification6 It classifies thoracolumbar fractures into 3 major groups, based on the mechanism of injury.and each of them subdivided to 3 subgroups.
- Compression B. Distraction C. multi-directional with translation Thoracolumbar AO spine injury score
What is being measured
The primary outcome is the main question the study is designed to answer.
AO Spine Injury Score
- injury morphology
- integrity of the PLC
- neurological status
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 posted13 Jun 2024
- Study start15 May 2024
- Primary completion25 May 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spine FractureStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Rady Youssef, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458309
- Sponsor's protocol ID
- soh_med_24_05_04ms
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hu R, Mustard CA, Burns C. Epidemiology of incident spinal fracture in a complete population. Spine (Phila Pa 1976). 1996 Feb 15;21(4):492-9. doi: 10.1097/00007632-199602150-00016.
PubMed 8658254Tran NT, Watson NA, Tencer AF, Ching RP, Anderson PA. Mechanism of the burst fracture in the thoracolumbar spine. The effect of loading rate. Spine (Phila Pa 1976). 1995 Sep 15;20(18):1984-8. doi: 10.1097/00007632-199509150-00004.
PubMed 8578372Bohlman HH. Treatment of fractures and dislocations of the thoracic and lumbar spine. J Bone Joint Surg Am. 1985 Jan;67(1):165-9. No abstract available.
PubMed 3881446McAfee PC, Yuan HA, Fredrickson BE, Lubicky JP. The value of computed tomography in thoracolumbar fractures. An analysis of one hundred consecutive cases and a new classification. J Bone Joint Surg Am. 1983 Apr;65(4):461-73.
PubMed 6833320
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Spine Fractures According to The Thoracolumbar AO Spine Injury Score
- ClinicalTrials.gov ID
- NCT06458309
- Acronym / sponsor ID
- soh_med_24_05_04ms
- Conditions
- Spine Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 25 May 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 13 Jun 2024 (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.
Each year, there are approximately 5 million new vertebral fractures worldwide1. Most of these fractures involve the thoracolumbar or lumbar spines. The thoracolumbar junction, due to its mechanical transition zone, and the lumbar spine, due to its absence of stabilizing articulations with the ribs, lordotic posture and more sagittal oriented facet joints, are vulnerable for involvement in spinal injuries2.
Burst fractures occurs frequently in high-energy traumas which are most commonly associated with falls and traffic accidents.3
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1-Skeletally mature patients (18yrs and older). 2-Thoracolumbar fractures.
Key exclusion criteria (1 listed)
- 1-skeletally immature patients. 2-pathological fractures.
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 |
|---|---|---|
| spine surgeryAO Classification6 It classifies thoracolumbar fractures into 3 major groups, based on the mechanism of injury.and each of them subdivided to 3 subgroups. A. Compression B. Distraction C. multi-directional with translation Thoracolumbar AO spine injury score | Procedure or surgery | – |
Primary outcome
AO Spine Injury Score
Time frame: 1 year
* injury morphology * integrity of the PLC * neurological status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 8658254Hu R, Mustard CA, Burns C. Epidemiology of incident spinal fracture in a complete population. Spine (Phila Pa 1976). 1996 Feb 15;21(4):492-9. doi: 10.1097/00007632-199602150-00016.
- Background: PubMed 8578372Tran NT, Watson NA, Tencer AF, Ching RP, Anderson PA. Mechanism of the burst fracture in the thoracolumbar spine. The effect of loading rate. Spine (Phila Pa 1976). 1995 Sep 15;20(18):1984-8. doi: 10.1097/00007632-199509150-00004.
- Background: PubMed 3881446Bohlman HH. Treatment of fractures and dislocations of the thoracic and lumbar spine. J Bone Joint Surg Am. 1985 Jan;67(1):165-9. No abstract available.
- Background: PubMed 6833320McAfee PC, Yuan HA, Fredrickson BE, Lubicky JP. The value of computed tomography in thoracolumbar fractures. An analysis of one hundred consecutive cases and a new classification. J Bone Joint Surg Am. 1983 Apr;65(4):461-73.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spine surgery in people with Spine Fracture, run by Sohag 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 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AO Spine Injury Score (time frame: 1 year). 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 NCT06458309, which also lists 4 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 13 Jun 2024.