CT Guided Percutaneous Vertebroplasty for Vertebral Non-union Following Posterior Fixation
NCT ID: NCT05071625
Last Updated: 2021-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2019-03-31
2021-09-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Absence of complications due to orthopaedic hardware;
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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CHU de NICE
Nice, , France
Countries
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Other Identifiers
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21Imagerie02
Identifier Type: -
Identifier Source: org_study_id
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