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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSPINEVISION SAS

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Infection, local to the operative site

Signed of local inflammation

Fever or leukocytosis

Morbid obesity

Trial design

Treatments tested in this trial

  • Transforaminal lumbar interbody fusion

Treatment groups

No treatment groups listed

Sponsors and collaborators

SPINEVISION SAS

Lead sponsor

EVAMED

Collaborator