Status:
ACTIVE_NOT_RECRUITING
Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine 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 ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease ...
Detailed Description
The Hexanium ACIF study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium ACIF system (retrospe...
Eligibility Criteria
Inclusion
- Patient planned for Hexanium ACIF system implant or patient implanted with Hexanium ACIF system (not prior July 2020)
- 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
- Signs 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 postoperative instructions
Key Trial Info
Start Date :
July 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2027
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06155409
Start Date
July 6 2021
End Date
July 31 2027
Last Update
December 15 2023
Active Locations (6)
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1
Clinique du Dos Terrefort
Bordeaux, France, 33520
2
Centre Hospitalier Privé de l'Europe
Le Port-Marly, France, 785620
3
CHRU de Nancy
Nancy, France, 54000
4
Polyclinique Majorelle
Nancy, France, 54000