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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05525052
Enrollment
24
Registered
2022-09-01
Start date
2021-01-01
Completion date
2021-08-15
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthrodesis, Joint Instability, Laminectomy, Post Laminectomy Syndrome, Spinal Disease, Spinal Stenosis, Zygapophyseal Joint Arthritis

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.

Interventions

OTHERTrans-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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
49 Years to 91 Years
Healthy volunteers
No

Inclusion criteria

s : - 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

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scale (VAS) of pain and Oswestry Disability Index (ODI)6 monthsPre- 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

MeasureTime frameDescription
painFrom 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
DisabilityFrom 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
Severe intraoperative and postoperative complicationsFrom 6 months (systematic consultation) to 4 yours (phone consultation)death , hemorrhage or infection requiring intensive care, post-operative neurological deficit
Need for further interventions afterward the procedureFrom 6 months (systematic consultation) to 4 yours (phone consultation)need for another surgery
Mean procedure timeAt inclusionthe mean time of procedures in minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026