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

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

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.

Study Overview

• Status: Completed
• Conditions: Vertebral Fracture; Vertebral Trauma
• Intervention / Treatment: Procedure: percutaneous vertebroplasty

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Nice, France, 06200
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients treated with a percutaneous vertebroplasty in our centre between 01/07/2015 and 01/07/2020 under combined CT/fluoroscopy guidance

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Spinal Injuries; Back Injuries; Spinal Fractures
• Other Study ID Numbers: 21Imagerie02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no data sharing plan has been established

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No