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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071625
Other study ID # 21Imagerie02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 31, 2019
Est. completion date September 15, 2021

Study information

Verified date September 2021
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 15, 2021
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CHU de NICE Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Technical success of the percutaneous vertebroplasty criteria of cement filling rate of vertebral body established by the authors 18 months
Secondary Safety of the procedure Complication rate during and after the procedure using CIRSE adverse event reports 18 months
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