Clinical Research Directory

Inclusion Criteria: 1. Skeletally mature adult ≥ 50 years of age at the time of surgery; 2. Currently in an independent living environment; 3. One- or two- level, acute (within twelve weeks of injury), thoracic or lumbar (T5-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI; 4. Adequate vertebral body height and geometry for insertion of the access instruments, as determined by the investigator and suitable candidate for standard kyphoplasty or vertebroplasty procedure; 5. NRS back pain score ≥ 7 on a 0-10 scale; 6. Has central pain over the spinous process upon palpation at the planned vertebral index level; 7. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures; 8. Personally signed and dated informed consent document prior to any study-related procedures indicating that the participant has been informed of all pertinent aspects of the study. Exclusion Criteria: 1. More than two levels with a vertebral compression fracture; 2. Previous treated or untreated vertebral compression fractures; 3. Uncorrectable coagulopathy; 4. Previous instrumented spinal surgery; 5. Significant vertebral collapse defined as \> 70% of original vertebral height, or a burst, or pedicle fracture; 6. Degenerative scoliosis, defined as Cobb angle \> 20° at any level; 7. Pre-existing neurological deficit or radicular pain that is not well defined or unstable; 8. Disabling back pain secondary to causes other than acute fracture; 9. Inability to walk or stand prior to sustaining the vertebral compression fracture; 10. Active systemic or local infection; 11. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease other than osteopenia or osteoporosis; 12. Morbid obesity defined as a body mass index \> 40 kg/m2; 13. Active malignancy. A participant with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years; 14. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol); 15. Currently involved in study of another investigational product that may affect outcome; 16. History of psychosocial disorders that could prevent accurate completion of self-reporting assessment scales; 17. Pregnant or planning to become pregnant during the study period; 18. Involved in active spinal litigation; 19. Involved in a workers compensation case; 20. Prisoner or ward of the state; 21. Unable to undergo a MRI/CT procedure.