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

Intervertebral Disc Degeneration Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06155409
• Other study ID #: SV004
• Status: Active, not recruiting
• Start date: July 6, 2021
• Est. completion date: July 31, 2027

Study information

• Verified date: December 2023
• Source: SpineVision
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
SpineVision	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Fusion success	Fusion rate will be analyzed and compared to the sate of the art.	Month 2, month 6, month 12 and month 24
Secondary	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
Secondary	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
Secondary	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