Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease

NCT05997121 | Recruiting FDA Device

• 1 other identifier: SV005
• Study Type: observational
• Target: 187
• Locations: 2 countries
• Sites: 6

Brief Summary

The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down). Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.

Conditions

Intervertebral Disc Degeneration

Keywords

Lumbar; Spine; Arthrodesis; Fusion; Stabilization; Oswestry disability index; Visual Analogue Score

Outcome Measures

Primary Outcomes (2)

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

  Rate of the 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 Oswestry Disability Index (ODI)

  ODI mean score at Month 12 will be compared to the ODI mean score at baseline.

  Month 12

Secondary Outcomes (4)

• Fusion success

  Month 2, month 6, month 12 and month 24

• Change of the Oswestry Disability Index (ODI)

  Month 2, month 6, and month 24

• Change of the back and leg 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

Transforaminal lumbar interbody fusion DEVICE

Transforaminal Lumbar Interbody Fusion indicates a surgical approach in the lumbar 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. Screws and rods are also added to maintain the level secure while the bones fuse together.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients eligible for treatment or already treated with the Hexanium TLIF system device will be offered to participate in the study; this applies to primary care clinic.

You may qualify if:

• Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)
• 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
• Signed 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

Bruges, France

RECRUITING

Clinique Saint Charles

Lyon, France

RECRUITING

Hopital privé Clairval

Marseille, France

RECRUITING

CHRU Nancy

Nancy, France

RECRUITING

Polyclinique Majorelle

Nancy, France

RECRUITING

Clinicque Générale Beaulieu

Geneva, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Ankylosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases

Study Officials

• Noel Graziani, Professor

  Hopital Privé Clairval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud Duchenes

CONTACT

+33 6 86 16 61 91; r.duchenes@spinevision.com

Hanta Ranaivoson

CONTACT

h.ranaivoson@spinevision.com

Study Design

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

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: July 9, 2021
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); CH (1)