Vertebral Augmentation and Percutaneous Fixation for Thoracolumbar Burst Fractures Requiring Corpectomy

NCT07645092 | Not Yet Recruiting

• 1 other identifier: 2026-A00934-47
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Thoracolumbar Burst Fractures

Outcome Measures

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.

  1 year

Secondary Outcomes (6)

• Assessment of the quality of radiological reduction

  1 year

• Assessment of the quality of radiological reduction

  1 year

• Assessment of the quality of radiological reduction

  1 year

• Assessment of clinical outcomes

  1 year

• Assessment of clinical outcomes

  1 year

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• Persons deprived of liberty by judicial or administrative decision, or persons under legal protection measures.
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Central Study Contacts

Mehdi BOUDISSA, Pr

CONTACT

0476763275; mboudissa@chu-grenoble.fr

Sarah PI KASSAR-UNEISI, Pharm D

CONTACT

0476767524; suneisi@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 12, 2026
• Study Start: June 15, 2026
• Primary Completion: June 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06