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Recruiting Observational

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

NCT05997121 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2021-07-09
Last updated
2026-03-18

Condition(s) studied

Intervertebral Disc Degeneration

Investigational drug(s) / intervention(s)

Transforaminal lumbar interbody fusion

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of serious adverse device and/or procedure related events — Month 24
    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.
  • Change of the Oswestry Disability Index (ODI) — Month 12
    ODI mean score at Month 12 will be compared to the ODI mean score at baseline.

Trial sites (6)

FacilityCityRegionStatus
Clinique du dos Terrefort Bruges France Recruiting
Clinique Saint Charles Lyon France Recruiting
Hopital privé Clairval Marseille France Recruiting
CHRU Nancy Nancy France Recruiting
Polyclinique Majorelle Nancy France Recruiting
Clinicque Générale Beaulieu Geneva Switzerland Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05997121 on ClinicalTrials.gov ↗ ← All trials in France