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

Exclusion Criteria

• •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