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OpenTrials
Completed

NCT Number: NCT07443267

Safety and Efficacy in Pain Reduction of CT-Guided Screw Fixation for Post-laminectomy Surgery Segment Spinal Instability: A Monocentric Study of 24 Patients (2023-2026)

Segmental instability of the spine following laminectomy or surgical arthrodesis is a common complication that often requires additional surgical intervention. CT-guided trans-facet screw fixation (TFF), performed under local anesthesia, is an innovative and minimally invasive technique that offers an alternative to open surgery under general anesthesia. This study aims to evaluate the effectiveness of CT-guided TFF fixation in reducing pain and improving daily activities in a population of 24 patients who have undergone prior spinal surgeries

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Key information

Age range

41 year–93 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU NICE

Nice, Alpes Maritimes, 0600, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Treated at the University Hospital of Nice between march 2023 and january 2026 with trans-facet arthrodesis for persistent lumbar segment instability following previous laminectomy surgery.
  • MRI or scintigraphy imaging showed signs suggestive of instability
  • Newly developed or worsening spondylolisthesis on successive examinations
  • Congestive arthropathy
  • Facet dislocation
  • Inflammatory disc disease (MODIC type 1 changes)

Exclusion criteria

  • Inability to tolerate the prone position under local anesthesia.
  • Presence of anatomical variants precluding the technical feasibility of transfacet fixation.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Change in pain levels between pre-intervention and post-intervention measurements.

    Time frame: Baseline) , 1 month post-intervention, 6 months post-intervention, and 1 year post-intervention.

    Pain assessed using the Visual Analog Scale (VAS) from 1 to 10,

Secondary outcomes

  1. Improvement in quality of life following the intervention.

    Time frame: Baseline ) 1 month post-intervention 6 months post-intervention and 1 year post-intervention.

    EQ-5D-3L questionnaire

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Post Laminectomy Spinal Instability: the Role of CT Guided Screw Fixation to Avoid New Surgery

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 31, 2026

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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