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

Completed

• Conditions: Vertebral Fracture; Vertebral Trauma

• Registration Number: NCT05071625
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-31
• Primary Completion: 2020-07-01
• Status Verified: 2021-09
• Study Completion: 2021-09-15
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Study First Posted: 2021-10-08
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Technical success of the percutaneous vertebroplasty	18 months	criteria of cement filling rate of vertebral body established by the authors
Safety of the procedure	18 months	Complication rate during and after the procedure using CIRSE adverse event reports

Trial Locations

Locations (1)

CHU de NICE; 🇫🇷 Nice, France