Actively Recruiting
Safety and Performance of the Hexanium TLIF System in Treating Skeletally Mature Patients With Degenerative Disc Disease
Led by SPINEVISION SAS · Updated on 2026-03-18
187
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
S
SPINEVISION SAS
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Hexanium TLIF system in treating adults with degenerative disc disease, a condition where spinal discs break down. This observational, international study includes patients who have already received or plan to receive the Hexanium TLIF implant. The study aims to follow participants for up to 24 months to collect important safety and effectiveness data. The treatment involves a Transforaminal Lumbar Interbody Fusion surgery, which fuses two vertebrae in the lower spine by removing the damaged disc and placing a cage to restore height, secured with screws and rods. Data will be collected from patients both retrospectively and prospectively at 2, 6, 12, and 24 months after the implant surgery to assess outcomes. Participants will be asked about their back and leg pain levels, disability, and any adverse effects since surgery. Researchers will measure fusion success, pain scores using the Visual Analogue Score (VAS), disability with the Oswestry Disability Index (ODI), and record any revision surgeries. The primary focus is on serious device- or procedure-related adverse events and changes in disability over one year. Follow-up spans two years to monitor long-term safety and performance.
CONDITIONS
Brief 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 already implanted with Hexanium TLIF system (implant not before July 2021)
- Patient is 18 years old or older
- Patient has provided signed informed consent or did not oppose data collection, according to local regulations
You will not qualify if you...
- Infection near the surgery site
- Signs of local inflammation
- Fever or high white blood cell count
- Morbid obesity
- Pregnancy
- Pediatric patients or those still growing skeletally
- Spondylolisthesis that cannot be reduced to Grade I
- Allergy or intolerance to metal
- Implant size unsuitable for successful result
- Inadequate tissue coverage or poor bone quality
- Implant use would interfere with anatomy or function
- Previous fusion at treatment level
- Cases not requiring bone graft or fusion
- Bone remodeling disorders including severe osteoporosis, osteopenia, spinal tumors, active infection, or metabolic bone disorders
- Conditions preventing benefit from spinal implant surgery such as tumors, congenital abnormalities, fractures, abnormal segmentation, or abnormal white blood counts
- Mental illness
- Unwillingness to follow post-operative instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo the Hexanium TLIF surgical implant procedure and receive immediate post-operative care.
1 visit (in-person)
Duration - Up to 24 months post surgery
Participants are monitored for safety and performance of the implant with assessments including pain and disability scores and fusion success.
Visits at Month 2, Month 6, Month 12, and Month 24
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
H
Hanta Ranaivoson
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
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