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ACTIVE NOT RECRUITING
NCT06155409

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

Sponsor: SPINEVISION SAS

View on ClinicalTrials.gov

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

Interventions

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.

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