Intervertebral Disc DegenerationFixedD3NCT06342765
Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
An observational study of Intervertebral Disc Degeneration, run by SPINEVISION SAS at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disc Degeneration
- What is being tested?
- Pedicle fixation surgery
- Type of treatment
- Medical device
- How many people
- 330 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Sep 2022to 30 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hanta Ranaivoson contact
France3 sites, 3 recruiting
- Recruiting
DOSCEA Pôle Rachis
Bayonne, 64100
Jean Bernard, secretariatdoscea@outlook.fr
- Recruiting
Clinique du dos Bordeaux-Terrefort
Bruges, 33520
Louis Boissière, Doctor, boissierelouis@gmail.com
- Recruiting
Orthéo Neurochirurgie
Saint-Etienne, 42199
Benjamin Pommier, Doctor, benjamin.pommier@neurochirurgie.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Intervertebral Disc Degeneration
- Being tested
- Pedicle fixation surgery
- Keywords
- Lumbar, Spine, Fusion, Posterior fixation, Oswestry disability index, Visual Analogue Score
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedicle fixation surgeryDevice
Pedicle fixation surgery indicates a surgical approach in the thoracic spine down to sacral spine to either support interbody fusion (fusion of the discal space between two vertebrae) , or to correct spinal deformity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious and non-serious device- and/or procedure-related adverse events
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.
Measured: Month 24
Change of the Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) mean score at Month 12 will be compared to the ODI mean score at baseline.
Measured: Month 12
Secondary outcomes (4)
Fusion success
Fusion rate will be analyzed and compared to the state if the art.
Measured: Month 2, month 6, month 12 and month 24
Change of the Oswestry Disability Index (ODI)
Mean Oswestry Disability Index (ODI) score evolution score will be analyzed.
Measured: Month 2, month 6, month 12 and month 24
Change of the back and leg Visual Analogue Score (VAS)
Back and leg Visual Analogue Score (VAS) pain assessment will be analyzed.
Measured: Month 2, month 6, month 12 and month 24
Incidence of revision surgery at implant site
Rate of revision surgery at implant site will be analyzed and compared to the state of the art.
Measured: Month 2, month 6, month 12 and month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start22 Sep 2022
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPINEVISION SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Benjamin Pommier, Principal investigator, Orthéo Neurochirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342765
- Sponsor's protocol ID
- SV009
- Acronym
- FixedD3
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06342765
- Acronym / sponsor ID
- FixedD3 / SV009
- Conditions
- Intervertebral Disc Degeneration
- Keywords
- Lumbar, Spine, Fusion, Posterior fixation, Oswestry disability index, Visual Analogue Score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- SPINEVISION SASIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 2 Apr 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Pedicle fixation surgeryPedicle fixation surgery indicates a surgical approach in the thoracic spine down to sacral spine to either support interbody fusion (fusion of the discal space between two vertebrae) , or to correct spinal deformity. | Device | – |
Primary outcome
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.
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.
4 secondary outcomes
Fusion success
Time frame: 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
Change of the back and leg Visual Analogue Score (VAS)
Time frame: Month 2, month 6, month 12 and month 24
Incidence of revision surgery at implant site
Time frame: Month 2, month 6, month 12 and month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Hanta Ranaivoson contact
Benjamin Pommier principal investigator
Orthéo Neurochirurgie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration, run by SPINEVISION SAS at 3 sites 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 3 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 18 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 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renaud Duchenes (+33 6 86 16 61 91, r.duchenes@spinevision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious and non-serious device- and/or procedure-related adverse events (time frame: Month 24). The study lists 2 primary outcomes in all. 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 18 Mar 2026.