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)

March 26, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 0600
        • CHU Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients consulting at the University Hospital of Nice (CHU de Nice).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohorte
Patients diagnosed with segment lumbar instability following spinal surgical procedures such as laminectomy .
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
Baseline) , 1 month post-intervention, 6 months post-intervention, and 1 year post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline ) 1 month post-intervention 6 months post-intervention and 1 year post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2023

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

February 3, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24Radiointerv01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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