AzTrials
AzTrials

Thoracolumbar Burst FracturesEXVERCORNCT07645092

Vertebral Augmentation and Percutaneous Fixation for Thoracolumbar Burst Fractures Requiring Corpectomy

An observational study of Thoracolumbar Burst Fractures, run by University Hospital, Grenoble.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Thoracolumbar Burst Fractures
How many people
30 participants
Where
No sites listed yet
Study dates
15 Jun 2026to 15 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 100 years
  • All sexes
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mehdi BOUDISSA, Pr contact

0476763275

mboudissa@chu-grenoble.fr

Sarah PI KASSAR-UNEISI, Pharm D contact

0476767524

suneisi@chu-grenoble.fr

About this study

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.

Read the detailed description

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (6)
  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. Assessment of the quality of radiological reduction

    AO Spine classification

    Measured: 1 year

  4. Assessment of clinical outcomes

    Clinical scores: ODI (Oswestry Disability Index)

    Measured: 1 year

  5. Assessment of clinical outcomes

    Clinical scores: VAS (Visual Analog Scale)

    Measured: 1 year

  6. Assessment of complications

    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°)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion15 Jun 2026 (estimated)
  4. Study completion15 Jun 2027 (estimated)

Resources

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
Other
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07645092
Sponsor's protocol ID
2026-A00934-47
Acronym
EXVERCOR
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
12 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Thoracolumbar Burst Fractures, run by University Hospital, Grenoble.

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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehdi BOUDISSA, Pr (0476763275, mboudissa@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate clinical and radiological outcomes of thoracolumbar burst fractures (LSC ≥7) treated with vertebral augmentation and percutaneous fixation. (time frame: 1 year). 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 12 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in