Percutaneous Trans-facet Screw Fixation Under CT-scan Guidance for Remaining Symptoms at a Distance of Previous Spinal Surgery

Percutaneous Trans-facet Screw Fixation Under CT-scan Guidance for Remaining Symptoms at a Distance of Previous Spinal Surgery: a New Treatment

Background : Segmental spinal instability after a laminectomy, and adjacent segment disease (ASD) at after an arthrodesis, are well-known concerns in spinal surgery, which may require re-interventions, usually by surgical arthrodesis, posing the problem of a new heavy intervention under general anesthesia, in often fragile patients.

Trans-facet fixation (TFF) under local anesthesia and double fluoroscopic and CT guidance is a minimally invasive technique involving the placement of screws through the posterior facet joints, improving spinal stability.

Purpose : The aim of our study is to evaluate the efficacy, in terms of pain reduction (VAS) and improvement of daily activities (ODI), of TFF under CT scan guidance in the context of low back pain and/or radiculalgia related to focal instability secondary to laminectomy or ASD.

Methods : TFF were performed in 24 patients having a history of spinal surgery such as laminectomy and/or classic surgical arthrodesis and remaining symptomatic, at Nice University Hospital between 2017 and 2021 Pre- and postoperative pain and disability levels were measured using the visual analogue scale (VAS) and the Oswestry Disability Index (ODI), collected prospectively at systematic 6-month and 1-year follow-up visits. Long term evolution were assessed by phone consultation.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis; Joint Instability; Arthrodesis; Spinal Disease; Laminectomy; Zygapophyseal Joint Arthritis; Post Laminectomy Syndrome
• Intervention / Treatment: Other: Trans-Facet fixation

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• France
  • Nice, France, 06001
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients treated at Nice University Hospital between 2017 and 2021 by transfacet arthrodesis, with history of spinal surgery ( laminectomy and/or classic arthrodesis), andsigns of subsequent instability.

Description

Inclusion criterias : - Patients treated at Nice University Hospital between 2017 and 2021 by transfacet arthrodesis,

• History of spinal surgery ( laminectomy and/or classic arthrodesis) - Clinical signs of subsequent instability(low back pain and/or radiculopathy).
• MRI or scintigraphy signs of instability or ASD :
• Spondylolisthesis appeared or increased on successive exams
• Facet dislocation
• Subchondral bone changes of the vertebral endplates (Modic 1)
• Insufficient improvment after epidural and posterior joint corticosteroid infiltrations

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; Patients having a history of spinal surgery such as laminectomy and/or classic surgical arthrodesis, and subsequent focal spinal, treated by transfacet arthrodesis under CT scan guidance	Other: Trans-Facet fixation; Trans-facet fixation (TFF) under local anesthesia and double fluoroscopic and CT guidance is a minimally invasive technique involving the placement of screws through the posterior facet joints, improving spinal stability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS) of pain and Oswestry Disability Index (ODI)	Pre- and postoperative pain were measured using the visual analogue scale (VAS), from 0 (no pain) to 10 (maximal pain) collected prospectively at systematic 6-month visit.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	Pre- and postoperative pain and disability levels were measured using the visual analogue scale (VAS)', from 0 (no pain) to 10 (maximal pain)collected prospectively at systematic 1-year follow-up visits. Long term evolution were assessed by phone consultation	From 6 months (systematic consultation) to 4 yours (phone consultation)
Disability	Pre- and postoperative disability were measured using the Oswestry Disability Index (ODI), from 0 to 100, collected prospectively at systematic 6-months and 1-year follow-up visits. Long term evolution were assessed by phone consultation	From 6 months (systematic consultation) to 4 yours (phone consultation)
Severe intraoperative and postoperative complications	death , hemorrhage or infection requiring intensive care, post-operative neurological deficit	From 6 months (systematic consultation) to 4 yours (phone consultation)
Need for further interventions afterward the procedure	need for another surgery	From 6 months (systematic consultation) to 4 yours (phone consultation)
Mean procedure time	the mean time of procedures in minutes	At inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Vincent SALA, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bone Diseases; Spinal Diseases; Spinal Stenosis; Joint Instability
• Other Study ID Numbers: 22-IMAGERIE-02

Drug and device information, study documents

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