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Completed

NCT Number: NCT05071625

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

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.

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Key information

Conditions

Vertebral Fracture Back Injuries Fractures, Bone Spinal Fractures Spinal Injuries Vertebral Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de NICE

Nice, 06200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Technical success of the percutaneous vertebroplasty

    Time frame: 18 months

    criteria of cement filling rate of vertebral body established by the authors

  2. Safety of the procedure

    Time frame: 18 months

    Complication rate during and after the procedure using CIRSE adverse event reports

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 8, 2021
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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