RCT on the Efficacy and Safety of Minimally Invasive SAIF Technique vs Spinal Fixation in Unstable Osteoporotic Vertebral Fractures

Inclusion Criteria: * one to two unstable OVFs\* type OF 3-5\*\* as assessed on CT scan, located between T2 and L5, of age \<3 months or with persistent edema on STIR, or with pseudarthrosis, at the index level * patients reporting pain upon mobilization * a diagnosis of osteoporosis, based on a DEXA T-score ≤ -2.5, or on a spontaneous thoracolumbar vertebral fracture or a vertebral fracture caused by minor trauma * able to read and speak the official language of the region of the site, * informed consent * additional OVF without unstable features (OF 1-2) allowed \*\* OF-Classification Exclusion Criteria: * compressive neurologic symptoms such as myelopathy or radiculopathy with motor deficit * acute infection * spinal malignancy * comorbid severe psychiatric conditions * known or suspected non-compliance, drug or alcohol abuse * known hypersensitivity or allergy to the investigational product * inability to follow the procedures of the study