Status:
RECRUITING
Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
Lead Sponsor:
SPINEVISION SAS
Collaborating Sponsors:
EVAMED
Conditions:
Intervertebral Disc Degeneration
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT05997121
Start Date
July 9 2021
End Date
October 30 2027
Last Update
August 21 2023
Active Locations (6)
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1
Clinique du dos Terrefort
Bruges, France
2
Clinique Saint Charles
Lyon, France
3
Hopital privé Clairval
Marseille, France
4
CHRU Nancy
Nancy, France