Clinical trial NCT06155409: Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease
Official title: Safety and Performance of the SpineVision Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease in Skeletally Mature Patients - HEXANIUM ACIF Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intervertebral Disc Degeneration
Keywords: Spine
Arthrodesis
Stabilization
Neck Disability Index
Visual Analogue Score
Cervical
Fusion
Lead sponsor: SPINEVISION SAS
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2023-12-04
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients elligible for treatment or already treated with the Hexanium ACIF system device will be offered to participate in the study; this applies to primary care clinic.

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 that occurs when the spinal disk breaks down) at the cervical spine level (C3-C7).

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: 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 (retrospective subjects) or subjects planned for treatment with the Hexanium ACIF system (prospective subjects) can be enrolled in hte study.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria: 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

Primary outcomes:
measure: Incidence of serious adverse device and/or procedure related events
timeFrame: Month 24
measure: Change of the Neck Disability Index (NDI)
timeFrame: Month 12
Secondary outcomes:
measure: Fusion success
timeFrame: Month 2, month 6, month 12 and month 24
measure: Change of the Neck Disability index (NDI)
timeFrame: Month 2, month 6, month 12 and month 24
measure: Change of the neck and arm Visual Analogue Score (VAS)
timeFrame: Month 2, month 6, month 12 and month 24
measure: Incidence of revision surgery at implant site
timeFrame: Month 2, month 6, month 12 and month 24
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique du Dos Terrefort
city: Le Port-Marly
country: France
facility: Centre Hospitalier Privé de l'Europe
city: Nancy
country: France
facility: CHRU de Nancy
city: Nancy
country: France
facility: Polyclinique Majorelle
city: Périgueux
country: France
facility: Hôpital Privé du Dos Francheville
city: Vantoux
country: France
facility: Hôpital Robert Schuman - UNEOS
Study officials:
affiliation: Centre Hospitalier de l'Europe
name: Patrice Lucas, Doctor
role: PRINCIPAL_INVESTIGATOR
References: