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Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
Sponsor: SPINEVISION SAS
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.
Official title: Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
187
Start Date
2021-07-09
Completion Date
2027-10-30
Last Updated
2026-03-18
Healthy Volunteers
Not specified
Conditions
Interventions
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.
Locations (6)
Clinique du dos Terrefort
Bruges, France
Clinique Saint Charles
Lyon, France
Hopital privé Clairval
Marseille, France
CHRU Nancy
Nancy, France
Polyclinique Majorelle
Nancy, France
Clinicque Générale Beaulieu
Geneva, Switzerland