CT Guided Percutaneous Vertebroplasty for Vertebral Non-union Following Posterior Fixation

Study Overview
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Brief Summary
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Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option. The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation. All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.

Official Title
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A Retrospectice Evaluation of the Feasibility and Usefulness of a Percutaneous Vertebroplasty Performed on Patients Treated With Posterior Fixation Suffering Non-union After a Traumatic Non-neurologic Vertebral Fracture

Conditions
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Vertebral Fracture, Vertebral Trauma

Intervention / Treatment
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* Procedure: percutaneous vertebroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PVP performed between July 2015-July 2020 under combined CT and fluoroscopy guidance; Previous PF for traumatic non-neurological thoracolumbar vertebral fracture; Imaging evidence of vertebral non-union; Pain and functional impairment persisting for more at least one month after PF; Informed patient consent for PVP procedure under CT and fluoroscopy guidance; Previous multidisciplinary case discussion between spine surgeons and interventional radiologists. Exclusion Criteria: Age inferior to 18 years old Absence of complications due to orthopaedic hardware;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: percutaneous vertebroplasty|percutaneous vertebroplasty under combined CT/fluoroscopy guidance for non-union after posterior fixation performed for a traumatic non-neurologic thoraco-lumbar vertebral fracture.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the procedure assessing consolidation and pain reduction 1 month after percutaneous vertebroplasty | Numeric Pain Rate Scale (from 0 to 10 points, where 0 no pain, 10 maximum pain) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success of the percutaneous vertebroplasty | criteria of cement filling rate of vertebral body established by the authors | 18 months | 
| Safety of the procedure | Complication rate during and after the procedure using CIRSE adverse event reports | 18 months |