Vertebral Augmentation and Percutaneous Fixation for Thoracolumbar Burst Fractures Requiring Corpectomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Hospital, Grenoble

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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.

Time frame
1 year

Secondary outcomes

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.

Time frame
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.

Time frame
1 year
3

Assessment of the quality of radiological reduction

AO Spine classification

Time frame
1 year
4

Assessment of clinical outcomes

Clinical scores: ODI (Oswestry Disability Index)

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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