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

NCT ID: NCT05071625

Last Updated: 2021-10-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-31

Study Completion Date

2021-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Vertebral Fracture Vertebral Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de NICE

Nice, , France

Site Status

Countries

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France

Other Identifiers

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21Imagerie02

Identifier Type: -

Identifier Source: org_study_id

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