Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment

NCT06342765 | Recruiting FDA Device

• 1 other identifier: SV009
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies. 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 Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery.

Conditions

Intervertebral Disc Degeneration

Keywords

Lumbar; Spine; Fusion; Posterior fixation; Oswestry disability index; Visual Analogue Score

Outcome Measures

Primary Outcomes (2)

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

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

  Month 24

• Change of the Oswestry Disability Index (ODI)

  Oswestry Disability Index (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, month 12 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

Pedicle fixation surgery DEVICE

Pedicle fixation surgery indicates a surgical approach in the thoracic spine down to sacral spine to either support interbody fusion (fusion of the discal space between two vertebrae) , or to correct spinal deformity.

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 eligible for treatment or already treated with one (1) of the SpineVision posterior fixation system (Lumis®, Plus® or Ulis®) will be offered to participate in the study; this applies to primary care clinic.

You may qualify if:

• Patient implanted with Lumis®, Plus® or Ulis® posterior fixation system
• Patient of 18 years old and more
• Patient has provided signed informed consent or did not oppose to his/her data collection, per local regulation

You may not qualify if:

• trauma (i.e., fracture or dislocation)
• Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel, etc.)
• Any other medical or surgical condition likely to compromise the success of instrumented surgery, such as the presence of a malignant tumor or serious congenital abnormalities, raised erythrocyte sedimentation rate not explained by other diseases, high white blood cell count or a tendency to low white blood cell count
• All cases not described in the indications
• Localized infection of the operative site
• All patients with insufficient tissue cover of the operative site
• Local signs of inflammation
• Fever or leukocytosis
• Pathological obesity
• Pregnancy
• Mental illness
• Rapidly evolving joint diseases, bone absorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this medical condition can limit the expected correction gain and stability of mechanical fixation
• All cases not requiring bone graft or bone fusion
• When pedicular screws are used, absence or malformation of pedicles
• All cases requiring a combination of different metals

Sponsors & Collaborators

• Slb Pharma: collaborator
• SPINEVISION SAS: lead

Study Sites (3)

DOSCEA Pôle Rachis

Bayonne, 64100, France

RECRUITING

Clinique du dos Bordeaux-Terrefort

Bruges, 33520, France

RECRUITING

Orthéo Neurochirurgie

Saint-Etienne, 42199, France

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Benjamin Pommier

  Orthéo Neurochirurgie

  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: March 26, 2024
• First Posted: April 2, 2024
• Study Start: September 22, 2022
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)