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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vertebral Fracture
- Sponsor
- Centre Hospitalier Universitaire de Nice
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Effectiveness of the procedure assessing consolidation and pain reduction 1 month after percutaneous vertebroplasty
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Effectiveness of the procedure assessing consolidation and pain reduction 1 month after percutaneous vertebroplasty
Time Frame: 18 months
Numeric Pain Rate Scale (from 0 to 10 points, where 0 no pain, 10 maximum pain)
Secondary Outcomes
- Technical success of the percutaneous vertebroplasty(18 months)
- Safety of the procedure(18 months)