Spine FractureNCT06374472
Surgical Treatment of Fractures of the Dorso-lombar Spine
An observational study of Spine Fracture, run by Ibn Jazzar Hospital at 1 site in Tunisia.
Trial summary
Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spine Fracture
- What is being tested?
- Osteosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2018to 1 Jan 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 80 cases of surgically treated thoracolumbar spine fractures
Who may be able to join
- the files of patients hospitalized for a recent fracture of the thoracolumbar spine within 12 months
Who cannot join
- Files with insufficient follow-up, patients lost to follow-up. patients presenting: A pathological fracture. Osteoporotic collapse. Material and Methods 3 Staged trauma to the spine. A fracture due to ankylosing spondylitis
Trial locations and contacts
1 site in 1 country.
About this study
Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis
Read the detailed description
Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rarely the vital prognosis .
The thoracolumbar spine has an extended transition zone between the tenth thoracic vertebra (T10) and the second lumbar vertebra (L2): the thoracolumbar hinge which, given its particular anatomical situation between a poorly mobile thoracic segment and a dynamic lumbar segment, is the predilection for occurrence of fractures and dislocations .
The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads.
The analysis of the lesion mechanism and its consequences depends on the understanding of the classification of these lesions which are essential for therapeutic conduct .
Surgical treatment constitutes a key element in the management strategy for these fractures
- Conditions
- Spine Fracture
- Being tested
- Osteosynthesis
- Keywords
- Fractures, Spine, Surgery, Treatment, Evaluation, Results
- Medical subject headings
- Spinal Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
Also called Release gestures, Arthrodesis, First approach
Some patients had osteosynthesis using a long construct, others had osteosynthesis using a short construct. Short constructs designated constructs only taking one level above and one level below the injury level (the fractured vertebra was not always included in the construct). The montages taking more than one level above or below the lesion were considered to be a long montage. Osteosynthesis is carried out using Cotrel Dubousset type rods and screws.
| Study group | Role | What they receive |
|---|---|---|
| 80 cases of thoracolumbar spine fractures | Not described Receives: Procedure: Osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age (in years)
average age of our patients was 38.25 years with extremes of 16 years and 68 years
Measured: from enrollment to the end of treatment at 4 years
Sex
Our series is characterized by a significant male predominance, it included 47 men (58.75%) and 33 women (41.25%), with a sex ratio of 1.42
Measured: from enrollment to the end of treatment at 4 years
Neurological status ( Frenkel classification)
3 Frankel A patients, 1 Frankel B patient, 6 Frankel C patients and 6 Frankel D
Measured: from enrollment to the end of treatment at 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Jan 2018
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Jazzar Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zied Mansi, Ibn Jazzar Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374472
- Sponsor's protocol ID
- IRB00001194
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: further use of this informations for others group works
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Fractures of the Dorso-lombar Spine
- ClinicalTrials.gov ID
- NCT06374472
- Acronym / sponsor ID
- IRB00001194
- Conditions
- Spine Fracture
- Keywords
- Fractures, Spine, Surgery, Treatment, Evaluation, Results
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ibn Jazzar HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 18 Apr 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.
Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis
Detailed description
Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rarely the vital prognosis .
The thoracolumbar spine has an extended transition zone between the tenth thoracic vertebra (T10) and the second lumbar vertebra (L2): the thoracolumbar hinge which, given its particular anatomical situation between a poorly mobile thoracic segment and a dynamic lumbar segment, is the predilection for occurrence of fractures and dislocations .
The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads.
The analysis of the lesion mechanism and its consequences depends on the understanding of the classification of these lesions which are essential for therapeutic conduct .
Surgical treatment constitutes a key element in the management strategy for these fractures
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 80 cases of thoracolumbar spine fractures | – | Procedure: Osteosynthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 80 cases of surgically treated thoracolumbar spine fractures
Key inclusion criteria (1 listed)
- the files of patients hospitalized for a recent fracture of the thoracolumbar spine within 12 months
Key exclusion criteria (1 listed)
- Files with insufficient follow-up, patients lost to follow-up. patients presenting: A pathological fracture. Osteoporotic collapse. Material and Methods 3 Staged trauma to the spine. A fracture due to ankylosing spondylitis
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 |
|---|---|---|
| OsteosynthesisAlso: Release gestures, Arthrodesis, First approachSome patients had osteosynthesis using a long construct, others had osteosynthesis using a short construct. Short constructs designated constructs only taking one level above and one level below the injury level (the fractured vertebra was not always included in the construct). The montages taking more than one level above or below the lesion were considered to be a long montage. Osteosynthesis is carried out using Cotrel Dubousset type rods and screws. | Procedure or surgery | 80 cases of thoracolumbar spine fractures |
Primary outcome
Age (in years)
Time frame: from enrollment to the end of treatment at 4 years
average age of our patients was 38.25 years with extremes of 16 years and 68 years
Sex
Time frame: from enrollment to the end of treatment at 4 years
Our series is characterized by a significant male predominance, it included 47 men (58.75%) and 33 women (41.25%), with a sex ratio of 1.42
Neurological status ( Frenkel classification)
Time frame: from enrollment to the end of treatment at 4 years
3 Frankel A patients, 1 Frankel B patient, 6 Frankel C patients and 6 Frankel D
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 18 Apr 2024.
- Individual participant dataSharing planned: No. further use of this informations for others group works
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Fracture, run by Ibn Jazzar Hospital at 1 site in Tunisia.
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 18 Apr 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 Tunisia. 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?
Age (in years) (time frame: from enrollment to the end of treatment at 4 years). 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 18 Apr 2024.