Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Transforaminal lumbar interbody fusion: Transforaminal Lumbar Interbody Fusion indicates a surgical approach in the lumbar 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. Screws and rods are also added to maintain the level secure while the bones fuse together.
Study summary
The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down).
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 Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.
Eligibility
Primary outcome measure(s)
- Incidence of serious adverse device and/or procedure related events — Month 24
Rate of the 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 Oswestry Disability Index (ODI) — Month 12
ODI mean score at Month 12 will be compared to the ODI mean score at baseline.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinique du dos Terrefort | Bruges | France | Recruiting |
| Clinique Saint Charles | Lyon | France | Recruiting |
| Hopital privé Clairval | Marseille | France | Recruiting |
| CHRU Nancy | Nancy | France | Recruiting |
| Polyclinique Majorelle | Nancy | France | Recruiting |
| Clinicque Générale Beaulieu | Geneva | Switzerland | Not Yet Recruiting |
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 NCT05997121 on ClinicalTrials.gov ↗ ← All trials in France