Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease

NCT06155409 | Active Not Recruiting FDA Device

• 1 other identifier: SV004
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 6

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.

Conditions

Intervertebral Disc Degeneration

Keywords

Spine; Arthrodesis; Stabilization; Neck Disability Index; Visual Analogue Score; Cervical; Fusion

Outcome Measures

Primary Outcomes (2)

• Incidence of serious adverse device and/or procedure related events

  Rate of serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.

  Month 24

• Change of the Neck Disability Index (NDI)

  Neck Disability Index (NDI) mean score at Month 12 will be compared to Neck Disability Index (NDI) mean score at baseline. Neck Disability Index (NDI) score varies between 0% and 100%, with highest score as worst outcome.

  Month 12

Secondary Outcomes (4)

• Fusion success

  Month 2, month 6, month 12 and month 24

• Change of the Neck Disability index (NDI)

  Month 2, month 6, month 12 and month 24

• Change of the neck and arm Visual Analogue Score (VAS)

  Month 2, month 6, month 12 and month 24

• Incidence of revision surgery at implant site

  Month 2, month 6, month 12 and month 24

Interventions

Anterior cervical interbody fusion DEVICE

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SPINEVISION SAS: lead
• EVAMED: collaborator

Study Sites (6)

Clinique du Dos Terrefort

Bordeaux, 33520, France

Location

Centre Hospitalier Privé de l'Europe

Le Port-Marly, 785620, France

Location

CHRU de Nancy

Nancy, 54000, France

Location

Polyclinique Majorelle

Nancy, 54000, France

Location

Hôpital Privé du Dos Francheville

Périgueux, 24000, France

Location

Hôpital Robert Schuman - UNEOS

Vantoux, 57070, France

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Ankylosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases

Study Officials

• Patrice Lucas, Doctor

  Centre Hospitalier de l'Europe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: July 6, 2021
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)