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

Safety and Performance of the SpineVision Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease in Skeletally Mature Patients - HEXANIUM ACIF Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intervertebral Disc Degeneration
• Intervention / Treatment: Device: Anterior cervical interbody fusion

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.

• Study Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33520
    • Clinique du dos Terrefort
  • Le Port-Marly, France, 785620
    • Centre Hospitalier Privé de l'Europe
  • Nancy, France, 54000
    • Polyclinique Majorelle
  • Nancy, France, 54000
    • CHRU de Nancy
  • Périgueux, France, 24000
    • Hôpital Privé du Dos Francheville
  • Vantoux, France, 57070
    • Hôpital Robert Schuman - UNEOS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of revision surgery at implant site	Rate of revision surgery at implant site will be analyzed and compared to the state of the art.	Month 2, month 6, month 12 and month 24
Fusion success	Fusion rate will be analyzed and compared to the sate of the art.	Month 2, month 6, month 12 and month 24
Change of the Neck Disability index (NDI)	Mean Neck Disability Index (NDI) score evolution will be analyzed. Neck Disability Index (NDI) score varies between 0% and 100%, with highest score as worst outcome.	Month 2, month 6, month 12 and month 24
Change of the neck and arm Visual Analogue Score (VAS)	Neck and arm Visual Analogue Score (VAS) assessments will be analyzed. Visual Analogue Score (VAS) is a pain scoring, with score varying from 0 (no pain) to 10 (worst pain, unbearable, excrutiating pain)	Month 2, month 6, month 12 and month 24

Collaborators and Investigators

• Sponsor: SPINEVISION SAS
• Collaborators: EVAMED
• Investigators: Principal Investigator: Patrice Lucas, Doctor, Centre Hospitalier de l'Europe

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cervical; Neck Disability Index; Spine; Fusion; Arthrodesis; Stabilization; Visual Analogue Score
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Spinal Diseases; Intervertebral Disc Degeneration; Ankylosis
• Other Study ID Numbers: SV004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No