FREE Study - Fracture Reduction Evaluation

Exclusion Criteria

• •Previous vertebroplasty;
• •Vertebral body fracture morphology prevents use of devices (such as endplate below pedicles);
• •Pedicle fractures;
• •Acute fracture(s) to be treated symptomatic \> 3 months at enrollment;
• •Pre-existing (not the result of the index fracture) neurological deficit or radicular pain that is not well defined or unstable;
• •Spinal cord compression or canal compromise requiring decompression;
• •Disabling back pain secondary to causes other than acute fracture;
• •Vertebral fracture due to primary or osteoblastic tumors;
• •Patient is currently on anticoagulation therapy that can not be interrupted;
• •Pre-existing conditions contrary to the kyphoplasty procedure:
• •* Systemic infection
• •* Local fractured vertebral body infection
• •* Temporarily non-reversible bleeding disorder
• •Known allergy to any of the drugs, bone void filler material or contrast medium used in the treatment of study subjects
• •Dementia and/or inability to give informed consent;
• •Inability to walk or stand prior to the vertebral body fracture (walking aids are allowed);
• •MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis);
• •Pregnancy
• •Participation in any other clinical trial within the last 30 days.