AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease

Recruitingn/aAges 18 Years - anyAllSPINEVISION SAS
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021) * Patient of 18 years old or more * Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation Exclusion Criteria: contra-indication * Infection, local to the operative site * Signed of local inflammation * Fever or leukocytosis * Morbid obesity * Pregnancy * Paediatric cases, or patient still having general skeletal growth * Spondylolisthesis unable to be reduced to Grade I * Suspected or documented allergy or intolerance to metal * Any case where the implant components selected for use would be too large or too small to achieve a successful result * Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality * Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance * Prior fusion at the level to be treated * Any case not needing a bone graft or fusion * Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis * Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count * Mental illness * Any patient unwilling to cooperate with post-operative instructions
💊

What it tests

  • Transforaminal lumbar interbody fusion
📍

Where

6 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy