NCT Number: NCT07645092
Vertebral Augmentation and Percutaneous Fixation for Thoracolumbar Burst Fractures Requiring Corpectomy
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.
Trial opening soon.
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Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Observational
About this study
Burst fractures account for approximately 17% of thoracolumbar fractures occurring after high-energy trauma. They are characterized by collapse of the anterior column, leading to loss of vertebral height and a local kyphotic deformity. Involvement of the middle column is a key factor in mechanical instability and largely explains the neurological risk, thus giving burst fractures a particular status among thoracolumbar injuries
In the 1990s, McCormack developed the Load Sharing Classification (LSC) to guide treatment strategy. A score below 7 supported isolated posterior fixation, whereas a score of 7 or higher led to the recommendation of a more invasive approach, including upfront corpectomy combined with supplementary anterior grafting to prevent early construct failure . Grobost demonstrated that corpectomies performed upfront yielded better functional outcomes than those performed secondarily in the context of pseudarthrosis . Although corpectomies provide reliable restoration of the anterior column, they are associated with significant morbidity, prompting the search for less invasive alternatives capable of restoring vertebral height and kyphosis while limiting complications.
Today, newer minimally invasive techniques allow reduction of vertebral height loss and local kyphosis while decreasing the mechanical load on posterior instrumentation . The systematic need for a major anterior procedure (grafting or corpectomy) may therefore be reconsidered. Among these techniques, vertebral expansion devices such as SpineJack have demonstrated the ability to effectively restore vertebral body height and maintain correction over time, particularly when combined with short posterior fixation.
Since 2005, publications on burst fractures have been predominantly limited to meta-analyses, with few new clinical series. Furthermore, available studies mainly focus on fractures of moderate severity, resulting in a lack of data on more severe fractures with an LSC score ≥ 7.
The aim of this study is to evaluate the clinical and radiological outcomes of patients treated at Grenoble Alpes University Hospital for thoracic and lumbar spine burst fractures with a Load Sharing Classification (LSC) score ≥7, managed with vertebral augmentation and percutaneous fixation.
Our hypothesis is that the combined use of percutaneous posterior fixation and anterior vertebral augmentation provides satisfactory clinical and radiological outcomes, thereby avoiding the need for corpectomy in thoracolumbar burst fractures (LSC ≥7).
DESIGN OF THE STUDY :Descriptive, single-center, observational cohort study, both retrospective and prospective, without a control group.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult patient at the time of the fracture.
- Patient who underwent posterior fixation (+1/-1 levels) combined with anterior vertebral augmentation:
Fracture with a Load Sharing Classification (LSC) score ≥ 7 Single vertebral level involved Percutaneous surgery
- Preoperative CT scans (thoracic and lumbar spine)
- Postoperative CT scans (thoracic and lumbar spine)
Exclusion criteria
- Persons deprived of liberty by judicial or administrative decision, or persons under legal protection measures.
- Non-inclusion criteria include:
Performance of a laminectomy Pathological fractures Fractures classified as type C or B2 according to the AO Spine classification Presence of severe scoliosis Neurological deficit More than one vertebral fracture
Treatment and study plan
Primary outcomes
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Evaluate clinical and radiological outcomes of thoracolumbar burst fractures (LSC ≥7) treated with vertebral augmentation and percutaneous fixation.
Time frame: 1 year
Absence of the need for secondary corpectomy due to pseudarthrosis and/or fixation failure.
Secondary outcomes
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Assessment of the quality of radiological reduction
Time frame: 1 year
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.
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Assessment of the quality of radiological reduction
Time frame: 1 year
Measurement of regional kyphosis, local kyphosis, and mean vertebral height preoperatively, postoperatively, and at 1-year follow-up.
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Assessment of the quality of radiological reduction
Time frame: 1 year
AO Spine classification
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Assessment of clinical outcomes
Time frame: 1 year
Clinical scores: ODI (Oswestry Disability Index)
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Assessment of clinical outcomes
Time frame: 1 year
Clinical scores: VAS (Visual Analog Scale)
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Assessment of complications
Time frame: 1 year
Complications: reoperation(s), infection, wound healing disorders, hardware failure, hardware-related discomfort and hardware removal, pseudarthrosis, and secondary collapse after hardware removal (loss of vertebral height or kyphosis >10°)
Study contacts
Contact information is provided by the study sponsor or research team.
Mehdi BOUDISSA, Pr
CONTACT
Sarah PI KASSAR-UNEISI, Pharm D
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Grenoble
Other
Registry information
Acronym: EXVERCOR
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Jun 12, 2026
- Registry last updated
- Jun 12, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.