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Completed

NCT Number: NCT05525052

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

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.

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Key information

Age range

49 year–91 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, 06001, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans-Facet fixation

Other

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.

Primary outcomes

  1. Visual analogue scale (VAS) of pain and Oswestry Disability Index (ODI)

    Time frame: 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 outcomes

  1. pain

    Time frame: 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

  2. Disability

    Time frame: 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

  3. Severe intraoperative and postoperative complications

    Time frame: From 6 months (systematic consultation) to 4 yours (phone consultation)

    death , hemorrhage or infection requiring intensive care, post-operative neurological deficit

  4. Need for further interventions afterward the procedure

    Time frame: From 6 months (systematic consultation) to 4 yours (phone consultation)

    need for another surgery

  5. Mean procedure time

    Time frame: At inclusion

    the mean time of procedures in minutes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 1, 2022
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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