Intervertebral Disc DegenerationNCT06155409
Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease
An observational study of Intervertebral Disc Degeneration, run by SPINEVISION SAS at 6 sites in France.
Trial summary
The goal of this observational study is to confirm the safety and efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk breaks down) at the cervical spine level (C3-C7). 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?
- Anterior cervical interbody fusion
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 6 sitesFrance
- Study dates
- 6 Jul 2021to 31 Jul 2027
- 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 elligible for treatment or already treated with the Hexanium ACIF system device will be offered to participate in the study; this applies to primary care clinic.
Who may be able to join
- Patient planned for Hexanium ACIF system implant or patient implanted with Hexanium ACIF system (not prior July 2020)
- Patient of 18 years old or more
- Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation
Who cannot join
- Infection, local to the operative site
- Signs of local inflammation
- Fever or leukocytosis
- Morbid obesity
- Pregnancy
- Paediatric cases, or patient still having general skeletal growth
Show all 17Show fewer
- Spondylolisthesis unable to be reduced to Grade I
- Suspected or documented allergy or intolerance to metal
- Any case where the implant components selected for use would be too large or too small to achieve a successful result
- Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
- Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
- Prior fusion at the level to be treated
- Any case not needing a bone graft or fusion
- Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
- Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count
- Mental illness
- Any patient unwilling to cooperate with postoperative instructions
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Clinique du Dos Terrefort
Bordeaux, 33520
Centre Hospitalier Privé de l'Europe
Le Port-Marly, 785620
CHRU de Nancy
Nancy, 54000
Polyclinique Majorelle
Nancy, 54000
Hôpital Privé du Dos Francheville
Périgueux, 24000
Hôpital Robert Schuman - UNEOS
Vantoux, 57070
About this study
Official title: Safety and Performance of the SpineVision Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease in Skeletally Mature Patients - HEXANIUM ACIF Study
The goal of this observational study is to confirm the safety and efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk breaks down) at the cervical spine level (C3-C7).
Part of their standard of care, participants will be questioned on their neck and arm pains, their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium ACIF system implant surgery.
Read the detailed description
The Hexanium ACIF study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium ACIF system (retrospective subjects) or subjects planned for treatment with the Hexanium ACIF system (prospective subjects) can be enrolled in hte study.
Standard of care subjects data up to twenty four (24) months post Hexanium ACIF system implant procedure will be collected; key data include neck and arm Visual Analogue Score (VAS), Neck Disability Index (NDI) score, and adverse events.
Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.
- Conditions
- Intervertebral Disc Degeneration
- Being tested
- Anterior cervical interbody fusion
- Keywords
- Spine, Arthrodesis, Stabilization, Neck Disability Index, Visual Analogue Score, Cervical, Fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cervical interbody fusionDevice
Anterior cervical interbody fusion indicates a surgical approach in the cervical spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse device and/or procedure related events
Rate of serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.
Measured: Month 24
Change of the Neck Disability Index (NDI)
Neck Disability Index (NDI) mean score at Month 12 will be compared to Neck Disability Index (NDI) mean score at baseline.
Neck Disability Index (NDI) score varies between 0% and 100%, with highest score as worst outcome.
Measured: Month 12
Secondary outcomes (4)
Fusion success
Fusion rate will be analyzed and compared to the sate of the art.
Measured: Month 2, month 6, month 12 and month 24
Change of the Neck Disability index (NDI)
Mean Neck Disability Index (NDI) score evolution will be analyzed. Neck Disability Index (NDI) score varies between 0% and 100%, with highest score as worst outcome.
Measured: Month 2, month 6, month 12 and month 24
Change of the neck and arm Visual Analogue Score (VAS)
Neck and arm Visual Analogue Score (VAS) assessments will be analyzed. Visual Analogue Score (VAS) is a pain scoring, with score varying from 0 (no pain) to 10 (worst pain, unbearable, excrutiating pain)
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 posted4 Dec 2023
- Study start6 Jul 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPINEVISION SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Patrice Lucas, Doctor, Principal investigator, Centre Hospitalier de l'Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155409
- Sponsor's protocol ID
- SV004
- Status last verified
- Mar 2026
- First submitted
- 23 Nov 2023
- 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 Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease in Skeletally Mature Patients - HEXANIUM ACIF Study
- ClinicalTrials.gov ID
- NCT06155409
- Acronym / sponsor ID
- SV004
- Conditions
- Intervertebral Disc Degeneration
- Keywords
- Spine, Arthrodesis, Stabilization, Neck Disability Index, Visual Analogue Score, Cervical, Fusion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (actual)
- Lead sponsor
- SPINEVISION SASIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Dec 2023 (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 efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk breaks down) at the cervical spine level (C3-C7).
Part of their standard of care, participants will be questioned on their neck and arm pains, their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium ACIF system implant surgery.
Detailed description
The Hexanium ACIF study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium ACIF system (retrospective subjects) or subjects planned for treatment with the Hexanium ACIF system (prospective subjects) can be enrolled in hte study.
Standard of care subjects data up to twenty four (24) months post Hexanium ACIF system implant procedure will be collected; key data include neck and arm Visual Analogue Score (VAS), Neck Disability Index (NDI) score, and adverse events.
Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.
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 elligible for treatment or already treated with the Hexanium ACIF system device will be offered to participate in the study; this applies to primary care clinic.
Key inclusion criteria (3 listed)
- Patient planned for Hexanium ACIF system implant or patient implanted with Hexanium ACIF system (not prior July 2020)
- Patient of 18 years old or more
- Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation
Key exclusion criteria (17 listed)
- Infection, local to the operative site
- Signs of local inflammation
- Fever or leukocytosis
- Morbid obesity
- Pregnancy
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 |
|---|---|---|
| Anterior cervical interbody fusionAnterior cervical interbody fusion indicates a surgical approach in the cervical spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height. | Device | – |
Primary outcome
Incidence of serious adverse device and/or procedure related events
Time frame: Month 24
Rate of serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.
Change of the Neck Disability Index (NDI)
Time frame: Month 12
Neck Disability Index (NDI) mean score at Month 12 will be compared to Neck Disability Index (NDI) mean score at baseline. Neck Disability Index (NDI) score varies between 0% and 100%, with highest score as worst outcome.
4 secondary outcomes
Fusion success
Time frame: Month 2, month 6, month 12 and month 24
Change of the Neck Disability index (NDI)
Time frame: Month 2, month 6, month 12 and month 24
Change of the neck and arm 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. This study is not recruiting at the moment.
Patrice Lucas, Doctor principal investigator
Centre Hospitalier de l'Europe
6 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 6 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 17 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: under way, not looking for participants, 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 6 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?
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?
Incidence of serious adverse device and/or procedure related 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.