NCT06155409

Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease

Safety and Performance of the SpineVision Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease in Skeletally Mature Patients - HEXANIUM ACIF Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 148 (actual)
• Sponsor: SPINEVISION SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-07-06
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2023-12-04
• Last updated: 2026-03-18

Locations

6 sites across 1 country: France

Regulatory

• FDA-regulated device study