- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06374472
Surgical Treatment of Fractures of the Dorso-lombar Spine
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kairouan, Tunisia, 3190
- IBN jazzar hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- the files of patients hospitalized for a recent fracture of the thoracolumbar spine within 12 months
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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80 cases of thoracolumbar spine fractures
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age (in years)
Time Frame: from enrollment to the end of treatment at 4 years
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average age of our patients was 38.25 years with extremes of 16 years and 68 years
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from enrollment to the end of treatment at 4 years
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Sex
Time Frame: from enrollment to the end of treatment at 4 years
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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
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from enrollment to the end of treatment at 4 years
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Neurological status ( Frenkel classification)
Time Frame: from enrollment to the end of treatment at 4 years
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3 Frankel A patients, 1 Frankel B patient, 6 Frankel C patients and 6 Frankel D
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from enrollment to the end of treatment at 4 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00001194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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