Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment (FixedD3)

March 16, 2026 updated by: SPINEVISION SAS

Safety and Performance of the SpineVision Posterior Fixation Systems Lumis®, Plus® and Ulis® in Thoracolumbar Spinal Degenerative Pathologies or Degenerative Disc Disease (DDD) Associated Pathologies Treatment - Fixed D3 Study

The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.

Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Fixed D3 study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with one (1) of the Spinevision posterior fixations systems (Lumis, Plus or Ulis) - retrospective subjects - or subjects planned for treatment with one of the Spinevision posterior fixation system (prospective subjects) can be enrolled in the study.

Standard of care data up to twenty four (24) months post Spinevision posterior fixation system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS) pain, Oswestry Disability Index (ODI) score, and adverse events.

Data will be collected at pre-operative, per-operative, and post-operative Month 2, Month 6, Month 12 and Month 24.

Study Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

All patients eligible for treatment or already treated with one (1) of the SpineVision posterior fixation system (Lumis®, Plus® or Ulis®) will be offered to participate in the study; this applies to primary care clinic.

Description

Inclusion Criteria:

  • Patient implanted with Lumis®, Plus® or Ulis® posterior fixation system
  • Patient of 18 years old and more
  • Patient has provided signed informed consent or did not oppose to his/her data collection, per local regulation

Exclusion Criteria: contra-indication

  • trauma (i.e., fracture or dislocation)
  • Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel, etc.)
  • Any other medical or surgical condition likely to compromise the success of instrumented surgery, such as the presence of a malignant tumor or serious congenital abnormalities, raised erythrocyte sedimentation rate not explained by other diseases, high white blood cell count or a tendency to low white blood cell count
  • All cases not described in the indications
  • Localized infection of the operative site
  • All patients with insufficient tissue cover of the operative site
  • Local signs of inflammation
  • Fever or leukocytosis
  • Pathological obesity
  • Pregnancy
  • Mental illness
  • Rapidly evolving joint diseases, bone absorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this medical condition can limit the expected correction gain and stability of mechanical fixation
  • All cases not requiring bone graft or bone fusion
  • When pedicular screws are used, absence or malformation of pedicles
  • All cases requiring a combination of different metals
  • All patients not agreeing to comply with post-operative instructions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious and non-serious device- and/or procedure-related adverse events
Time Frame: Month 24
Rate of the serious and non-serious device- and/or procedure-related adverse events will be analyzed and compared to the state of the art.
Month 24
Change of the Oswestry Disability Index (ODI)
Time Frame: Month 12
Oswestry Disability Index (ODI) mean score at Month 12 will be compared to the ODI mean score at baseline.
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of revision surgery at implant site
Time Frame: Month 2, month 6, month 12 and month 24
Rate of revision surgery at implant site will be analyzed and compared to the state of the art.
Month 2, month 6, month 12 and month 24
Fusion success
Time Frame: Month 2, month 6, month 12 and month 24
Fusion rate will be analyzed and compared to the state if the art.
Month 2, month 6, month 12 and month 24
Change of the Oswestry Disability Index (ODI)
Time Frame: Month 2, month 6, month 12 and month 24
Mean Oswestry Disability Index (ODI) score evolution score will be analyzed.
Month 2, month 6, month 12 and month 24
Change of the back and leg Visual Analogue Score (VAS)
Time Frame: Month 2, month 6, month 12 and month 24
Back and leg Visual Analogue Score (VAS) pain assessment will be analyzed.
Month 2, month 6, month 12 and month 24

Collaborators and Investigators

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

Sponsor

SPINEVISION SAS

Collaborators

Slb Pharma

Investigators

  • Principal Investigator: Benjamin Pommier, Orthéo Neurochirurgie

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)

September 22, 2022

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SV009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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