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

NCT05071625 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-10-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2020-07-01
Completion
2021-09-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05071625 on ClinicalTrials.gov