Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Anterior cervical interbody fusion: 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.
Study 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).
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.
Eligibility
Primary outcome measure(s)
- Incidence of serious adverse device and/or procedure related events — 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) — 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.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinique du Dos Terrefort | Bordeaux | France | |
| Centre Hospitalier Privé de l'Europe | Le Port-Marly | France | |
| CHRU de Nancy | Nancy | France | |
| Polyclinique Majorelle | Nancy | France | |
| Hôpital Privé du Dos Francheville | Périgueux | France | |
| Hôpital Robert Schuman - UNEOS | Vantoux | France |
More SPINEVISION SAS trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06155409 on ClinicalTrials.gov ↗ ← All trials in France