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Safety and Performance of the SpineVision Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease in Skeletally Mature Patients - HEXANIUM ACIF Study
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 6, 2021
Primary Completion Date
July 31, 2027
Completion Date
July 31, 2027
Last Updated
March 18, 2026
148
ACTUAL participants
Anterior cervical interbody fusion
DEVICE
Lead Sponsor
SPINEVISION SAS
Collaborators
NCT05648474
NCT03076658
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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