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.
The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF (prospective subjects) can be enrolled in the study. Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS), Oswestry Disability Index (ODI) score, and adverse events. Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.
Study Type
OBSERVATIONAL
Enrollment
187
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.
Clinique du dos Terrefort
Bruges, France
RECRUITINGClinique Saint Charles
Lyon, France
RECRUITINGHopital privé Clairval
Marseille, France
RECRUITINGCHRU Nancy
Nancy, France
RECRUITINGPolyclinique Majorelle
Nancy, France
RECRUITINGClinicque Générale Beaulieu
Geneva, Switzerland
NOT_YET_RECRUITINGIncidence of serious adverse device and/or procedure related events
Rate of the serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.
Time frame: Month 24
Change of the Oswestry Disability Index (ODI)
ODI mean score at Month 12 will be compared to the ODI mean score at baseline.
Time frame: Month 12
Fusion success
Fusion rate will be analyzed and compared to the state of the art.
Time frame: Month 2, month 6, month 12 and month 24
Change of the Oswestry Disability Index (ODI)
Mean ODI score evolution score will be analyzed.
Time frame: Month 2, month 6, and month 24
Change of the back and leg Visual Analogue Score (VAS)
Back and leg VAS assessment will be analyzed.
Time frame: Month 2, month 6, month 12 and month 24
Incidence of revision surgery at implant site
Rate of revision surgery at implant site will be analyzed and compared to the state of the art.
Time frame: Month 2, month 6, month 12 and month 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.