Actively Recruiting
Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
Led by SPINEVISION SAS · Updated on 2026-03-18
187
Participants Needed
6
Research Sites
329 weeks
Total Duration
On this page
Sponsors
S
SPINEVISION SAS
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient planned for Hexanium TLIF system implant or patient implanted 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
You will not qualify if you...
- Infection local to the operative site
- Signs of local inflammation
- Fever or leukocytosis
- Morbid obesity
- Pregnancy
- Pediatric cases or patients still having general skeletal growth
- Spondylolisthesis unable to be reduced to Grade I
- Suspected or documented allergy or intolerance to metal
- Implant components too large or too small to achieve success
- Inadequate tissue coverage over the operative site or inadequate bone stock or quality
- Implant use interfering with anatomical structures or expected physiological performance
- Prior fusion at the level to be treated
- Cases not needing a bone graft or fusion
- Abnormalities affecting normal bone remodeling such as severe osteoporosis, bone absorption, osteopenia, tumors involving the spine, active infection, or metabolic disorders affecting osteogenesis
- Conditions precluding benefit from spinal implant surgery such as tumors, congenital abnormalities, fractures near the operating site, abnormal segmentation rate, elevated white blood count or marked left shift in WBC differential count
- Mental illness
- Patient unwilling to cooperate with post-operative instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Clinique du dos Terrefort
Bruges, France
Actively Recruiting
2
Clinique Saint Charles
Lyon, France
Actively Recruiting
3
Hopital privé Clairval
Marseille, France
Actively Recruiting
4
CHRU Nancy
Nancy, France
Actively Recruiting
5
Polyclinique Majorelle
Nancy, France
Actively Recruiting
6
Clinicque Générale Beaulieu
Geneva, Switzerland
Not Yet Recruiting
Research Team
R
Renaud Duchenes
CONTACT
H
Hanta Ranaivoson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here