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

Completed

• Conditions: Laminectomy; Arthrodesis; Spinal Stenosis; Joint Instability; Spinal Disease; Zygapophyseal Joint Arthritis; Post Laminectomy Syndrome
• Interventions: Other: Trans-Facet fixation

• Registration Number: NCT05525052
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-08-15
• Study Completion: 2021-08-15
• Status Verified: 2022-08
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-01
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Trans-Facet fixation	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

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) of pain and Oswestry Disability Index (ODI)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Need for further interventions afterward the procedure	From 6 months (systematic consultation) to 4 yours (phone consultation)	need for another surgery
Disability	From 6 months (systematic consultation) to 4 yours (phone consultation)	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
pain	From 6 months (systematic consultation) to 4 yours (phone consultation)	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
Mean procedure time	At inclusion	the mean time of procedures in minutes
Severe intraoperative and postoperative complications	From 6 months (systematic consultation) to 4 yours (phone consultation)	death , hemorrhage or infection requiring intensive care, post-operative neurological deficit

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France