SOFTBONEInossia® Cement Softener with PMMA for Vertebral Compression Fractures

Study start date: March 11, 2021

Inclusion Criteria: * Informed consent obtained before any study-related activities (study-related activities are any procedures that would not have been performed during normal management of the patient, i.e. standard of care); * Symptomatic osteoporotic vertebral compression fracture without prior or not responding to medical treatment within 6 months; * Maximum of 1 level of vertebral compression fractures eligible for treatment localized at level Th5 to L5 and verified by MRI or bone scan; * Height reduction of the affected vertebra(e) with an anterior wall compression of not exceeding 60% compared to the nearest normal vertebral body determined by X-ray; * Have pain correlating to the fractured levels requiring regular analgesic intake and/or causing substantial disability of daily life; * Pain score ≥ 40 mm measured by VAS correlating to at least one of the fracture levels (scale 0 - 100 mm) at the screening visit; * Oswestry Disability Index \> 20 (0 - 100 scale); * SF-12PCS Index \< 80 (0 - 100 scale); * Patient with a communicative ability to understand the procedure and participate in the study and comply with the follow up program. Exclusion Criteria: * Patients below 18 years; * Any burst fracture; * Unstable fractures defined by neurological deficit or interspinous process widening as evaluated by the Investigator, as well as kyphosis \> 30°, translation \> 4 mm; * Established or suspected malignancy of the fractured vertebra. Hemangioma of the fractured vertebra; * High energy trauma or clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis as suggested by progressive weakness; * Have neurologic symptoms or deficits, or radiculopathy related to the fractured vertebrae; * Patients with extremely high BMI, i.e. BMI ≥ 40; * Previously treated with vertebroplasty or kyphoplasty; * Patients with concomitant diseases which may be worsened by invasive treatment of the fracture such as e.g. severe cardiopulmonary dysfunction (including aortic aneurysm), as judged by the Investigator * Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re- initiation of anticoagulants; * Active systemic infection or local skin infection at the puncture site; * Pregnancy or breast-feeding; * Patients with known chemical dependency or drugs or with a medical history of drug abuse; * Patients who are serving prison sentence; * Have participated in another investigational study within 30 days prior to inclusion * Pacemaker * Previous or active radiotherapy affecting the spine