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

Intervertebral Disc Degeneration Clinical Trial

— FixedD3  

Official title:

Safety and Performance of the SpineVision Posterior Fixation Systems Lumis®, Plus® and Ulis® in Thoracolumbar Spinal Degenerative Pathologies or Degenerative Disc Disease (DDD) Associated Pathologies Treatment - Fixed D3 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342765
• Other study ID #: SV009
• Status: Recruiting
• Start date: September 22, 2022
• Est. completion date: May 30, 2028

Study information

• Verified date: April 2024
• Source: SpineVision
• Contact: Renaud Duchenes
• Phone: +33 6 86 16 61 91
• Email: r.duchenes[@]spinevision.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The Fixed D3 study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with one (1) of the Spinevision posterior fixations systems (Lumis, Plus or Ulis) - retrospective subjects - or subjects planned for treatment with one of the Spinevision posterior fixation system (prospective subjects) can be enrolled in the study. Standard of care data up to twenty four (24) months post Spinevision posterior fixation system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS) pain, Oswestry Disability Index (ODI) score, and adverse events. Data will be collected at pre-operative, per-operative, and post-operative Month 2, Month 6, Month 12 and Month 24.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: May 30, 2028
• Est. primary completion date: May 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Exclusion Criteria: contra-indication
• 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
• All patients not agreeing to comply with post-operative instructions

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration

Intervention

Device:
• Pedicle fixation surgery
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.

Locations

Country	Name	City	State
France	DOSCEA Pôle Rachis	Bayonne
France	Clinique du dos Bordeaux-Terrefort	Bruges
France	Orthéo Neurochirurgie	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
SpineVision	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Fusion success	Fusion rate will be analyzed and compared to the state if the art.	Month 2, month 6, month 12 and month 24
Secondary	Change of the Oswestry Disability Index (ODI)	Mean Oswestry Disability Index (ODI) score evolution score will be analyzed.	Month 2, month 6, month 12 and month 24
Secondary	Change of the back and leg Visual Analogue Score (VAS)	Back and leg Visual Analogue Score (VAS) pain assessment will be analyzed.	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