Segmental Instability Post-laminectomyNCT07443267
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)
An observational study of Segmental Instability Post-laminectomy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 41 to 93 years
- Conditions the study is for
- Segmental Instability Post-laminectomy
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2023to 3 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting at the University Hospital of Nice (CHU de Nice).
Who may be able to join
- 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)
Who cannot join
- Inability to tolerate the prone position under local anesthesia.
- Presence of anatomical variants precluding the technical feasibility of transfacet fixation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Segmental Instability Post-laminectomy
- Being tested
- No intervention
- Keywords
- Spinal Disease, Adjacent Segment Disease
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Cohorte | Patients diagnosed with segment lumbar instability following spinal surgical procedures such as laminectomy . Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain levels between pre-intervention and post-intervention measurements.
Pain assessed using the Visual Analog Scale (VAS) from 1 to 10,
Measured: 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.
EQ-5D-3L questionnaire
Measured: Baseline ) 1 month post-intervention 6 months post-intervention and 1 year post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start8 Mar 2023
- Primary completion30 Jan 2026
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Segmental Instability Post-laminectomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443267
- Sponsor's protocol ID
- 24Radiointerv01
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Laminectomy Spinal Instability: the Role of CT Guided Screw Fixation to Avoid New Surgery
- ClinicalTrials.gov ID
- NCT07443267
- Acronym / sponsor ID
- 24Radiointerv01
- Conditions
- Segmental Instability Post-laminectomy
- Keywords
- Spinal Disease, Adjacent Segment Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohorte | – | Other: No interventionPatients diagnosed with segment lumbar instability following spinal surgical procedures such as laminectomy . |
Who may qualify
- Ages
- 41 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting at the University Hospital of Nice (CHU de Nice).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to tolerate the prone position under local anesthesia.
- Presence of anatomical variants precluding the technical feasibility of transfacet fixation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Cohorte |
Primary outcome
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,
1 secondary outcome
Improvement in quality of life following the intervention.
Time frame: Baseline ) 1 month post-intervention 6 months post-intervention and 1 year post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Segmental Instability Post-laminectomy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.