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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525052
• Other study ID #: 22-IMAGERIE-02
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 49 Years to 91 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthrodesis
• Joint Instability
• Laminectomy
• Spinal Disease
• Spinal Diseases
• Spinal Stenosis

Intervention

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.

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	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	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)
Secondary	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)
Secondary	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)
Secondary	Need for further interventions afterward the procedure	need for another surgery	From 6 months (systematic consultation) to 4 yours (phone consultation)
Secondary	Mean procedure time	the mean time of procedures in minutes	At inclusion