Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
Recruiting now
Conditions studied: Intervertebral Disc Degeneration
In brief
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.
Key facts
- Study ID
- NCT05997121
- Run by
- SPINEVISION SAS
- People needed
- 187
- Starts
- 2021-07-09
- Expected to finish
- 2027-10-30
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Clinique du dos Terrefort — Bruges, France (enrolling)
- Clinique Saint Charles — Lyon, France (enrolling)
- Hopital privé Clairval — Marseille, France (enrolling)
- CHRU Nancy — Nancy, France (enrolling)
- Polyclinique Majorelle — Nancy, France (enrolling)
- Clinicque Générale Beaulieu — Geneva, Switzerland
Full record on ClinicalTrials.gov
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