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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05071625
Enrollment
10
Registered
2021-10-08
Start date
2019-03-31
Completion date
2021-09-15
Last updated
2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertebral Fracture, Vertebral Trauma

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.

Interventions

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of the procedure assessing consolidation and pain reduction 1 month after percutaneous vertebroplasty18 monthsNumeric Pain Rate Scale (from 0 to 10 points, where 0 no pain, 10 maximum pain)

Secondary

MeasureTime frameDescription
Technical success of the percutaneous vertebroplasty18 monthscriteria of cement filling rate of vertebral body established by the authors
Safety of the procedure18 monthsComplication rate during and after the procedure using CIRSE adverse event reports

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026