Investigating Bone Cement With or Without Inossia™ Cement Softener for Vertebral Compression Fractures

Inclusion Criteria:

• Informed consent obtained before any study-related activities (study-relatedactivities are any procedures that would not have been performed during normalmanagement of the patient, i.e. standard of care);
• Symptomatic osteoporotic vertebral compression fracture without prior or notresponding to medical treatment within 6 months;
• Maximum of 1 level of vertebral compression fractures eligible for treatment localizedat level Th5 to L5 and verified by MRI or bone scan;
• Height reduction of the affected vertebra(e) with an anterior wall compression of notexceeding 60% compared to the nearest normal vertebral body determined by X-ray;
• Have pain correlating to the fractured levels requiring regular analgesic intakeand/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 inthe 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 asevaluated by the Investigator, as well as kyphosis > 30°, translation > 4 mm;
• Established or suspected malignancy of the fractured vertebra. Hemangioma of thefractured vertebra;
• High energy trauma or clinical diagnosis of herniated nucleus pulposus or severespinal stenosis as suggested by progressive weakness;
• Have neurologic symptoms or deficits, or radiculopathy related to the fracturedvertebrae;
• 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 thefracture such as e.g. severe cardiopulmonary dysfunction (including aortic aneurysm),as judged by the Investigator
• Irreversible coagulopathy or bleeding disorder. Note regarding reversiblecoagulopathies: Patients on Coumadin or other anticoagulants may participate.Investigators should follow routine practices for perioperative discontinuation andre- 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 drugabuse;
• 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