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

NCT05071625 | Completed

• 1 other identifier: 21Imagerie02
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Fracture; Vertebral Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Technical success of the percutaneous vertebroplasty

  18 months

• Safety of the procedure

  18 months

Interventions

percutaneous vertebroplasty PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated with a percutaneous vertebroplasty in our centre between 01/07/2015 and 01/07/2020 under combined CT/fluoroscopy guidance

You may qualify if:

• 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.

You may not qualify if:

• Age inferior to 18 years old
• Absence of complications due to orthopaedic hardware;

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, 06200, France

Location

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Design

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

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: March 31, 2019
• Primary Completion: July 1, 2020
• Study Completion: September 15, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)