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Clinical Trial 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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05997121
Study type Observational
Source SpineVision
Contact Renaud Duchenes
Phone +33 6 86 16 61 91
Email r.duchenes@spinevision.com
Status Recruiting
Phase
Start date July 9, 2021
Completion date October 30, 2027

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