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Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease
Sponsor: SPINEVISION SAS
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
148
Start Date
2021-07-06
Completion Date
2027-07-31
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (6)
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