Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease
NCT ID: NCT06155409
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
148 participants
OBSERVATIONAL
2021-07-06
2027-07-31
Brief Summary
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Part of their standard of care, participants will be questioned on their neck and arm pains, their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium ACIF system implant surgery.
Detailed Description
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Standard of care subjects data up to twenty four (24) months post Hexanium ACIF system implant procedure will be collected; key data include neck and arm Visual Analogue Score (VAS), Neck Disability Index (NDI) score, and adverse events.
Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Interventions
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Anterior cervical interbody fusion
Anterior cervical interbody fusion indicates a surgical approach in the cervical spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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EVAMED
OTHER
SPINEVISION SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Patrice Lucas, Doctor
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier de l'Europe
Locations
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Clinique du Dos Terrefort
Bordeaux, , France
Centre Hospitalier Privé de l'Europe
Le Port-Marly, , France
CHRU de Nancy
Nancy, , France
Polyclinique Majorelle
Nancy, , France
Hôpital Privé du Dos Francheville
Périgueux, , France
Hôpital Robert Schuman - UNEOS
Vantoux, , France
Countries
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Other Identifiers
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SV004
Identifier Type: -
Identifier Source: org_study_id