NCT05997121

Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease

Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 187 (estimated)
• Sponsor: SPINEVISION SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed description

The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF (prospective subjects) can be enrolled in the study. Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS), Oswestry Disability Index (ODI) score, and adverse events. Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.

Conditions

• Intervertebral Disc Degeneration

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-07-09
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2023-08-18
• Last updated: 2026-03-18

Locations

6 sites across 2 countries: France, Switzerland

Regulatory

• FDA-regulated device study