NCT07443267

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
Last Updated

March 31, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

February 17, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Spinal DiseaseAdjacent Segment Disease

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (1)

  • Improvement in quality of life following the intervention.

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

Study Arms (1)

Cohorte

Patients diagnosed with segment lumbar instability following spinal surgical procedures such as laminectomy .

Other: No intervention

Interventions

No intervention

Cohorte

Eligibility Criteria

Age41 Years - 93 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 0600, France

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2026

First Posted

March 2, 2026

Study Start

March 8, 2023

Primary Completion

January 30, 2026

Study Completion

February 3, 2026

Last Updated

March 31, 2026

Record last verified: 2026-02

Locations