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

Vertebral Fracture Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071625
• Other study ID #: 21Imagerie02
• Status: Completed
• 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
• 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;

Related Conditions & MeSH terms

• Spinal Fractures
• Vertebral Fracture

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