About this trial
This study evaluates minimally invasive vertebral augmentation combined with percutaneous fixation for the treatment of severe thoracolumbar burst fractures. Traditionally, fractures with a Load Sharing Classification (LSC) score ≥7 require corpectomy, which is associated with significant morbidity. Newer techniques, such as vertebral expansion devices, may restore vertebral height and alignment while reducing the need for invasive anterior procedures. This study aims to assess their effectiveness in this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient at the time of the fracture.
Preoperative CT scans (thoracic and lumbar spine)
Postoperative CT scans (thoracic and lumbar spine)
Disqualifiers
Persons deprived of liberty by judicial or administrative decision, or persons under legal protection measures.
Trial population
In this study, all adult patients treated for thoracic and lumbar spine fractures with a Load Sharing Classification (LSC) score ≥ 7, who underwent posterior fixation (+1/-1 levels) combined with anterior vertebral augmentation, will be eligible for inclusion. Epidemiological data, preoperative management, AO Spine classification \[1\], operative data, and radiological findings are collected and analyzed. Data collection is performed using patients' medical records and during a follow-up telephone visit.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Evaluate clinical and radiological outcomes of thoracolumbar burst fractures (LSC ≥7) treated with vertebral augmentation and percutaneous fixation.
Absence of the need for secondary corpectomy due to pseudarthrosis and/or fixation failure.
Secondary outcomes
Assessment of the quality of radiological reduction
Radiological criteria: Fracture healing is assessed on standard radiographs based on cortical continuity, disappearance of fracture lines, maintenance of vertebral body height, absence of progression of kyphotic deformity, and absence of hardware failure. Healing is classified as complete, partial, or absent.
Assessment of the quality of radiological reduction
Measurement of regional kyphosis, local kyphosis, and mean vertebral height preoperatively, postoperatively, and at 1-year follow-up.
Assessment of the quality of radiological reduction
AO Spine classification
Assessment of clinical outcomes
Clinical scores: ODI (Oswestry Disability Index)
Locations
Sponsors and contacts
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