A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis

Inclusion Criteria: Are at least 18 years of age Have sustained a painful osteoporotic vertebral compression fracture (VCF) for at least 4 weeks but no longer than 1 year or have radiographic evidence of at least 5% worsening vertebral collapse as compared to previous radiographic evidence Give written Informed Consent to participate in the study and be willing to comply with protocol requirements Have pain requiring the regular use of analgesics or have a substantially altered life-style due to pain or disability Have central pain over the spinous process upon palpation at the planned level(s) Are appropriately communicative to verbalize and differentiate with regard to location and intensity of their pain Are physically and mentally willing and able to comply with the clinical and radiographic follow-up schedule Have radiographic evidence of one or two, Grade 1 or greater according to Genant's criteria, osteoporotic VCF(s) between (and including) the level of the sixth (6th) thoracic to the fifth (5th) lumbar Have an acute or persistent (not healed) fracture demonstrated by magnetic resonance imaging (MRI) or bone scan Have a patient self-assessment VAS score >= 50 mm at the pre-treatment visit Have a 30% or greater disability score on the baseline ODI (version 2.0). Exclusion Criteria: Have significant vertebral collapse defined as more than 70% of original vertebral height, or a burst or pedicle fracture with posterior cortical wall disruption Have posterior vertebral wall displacement occupying more than 20% of the cross sectional area of the spinal canal Have neurologic symptoms or deficits, or radiculopathy related to the VCF Have pain based on a clinical diagnosis of herniated nucleus pulposus, high energy trauma, severe spinal stenosis as evidenced by progressive weakness or paralysis, or bone tumor at the level(s) of pathology as evidenced by computed tomography (CT) scan Have indications of instability related to the VCF at the level to be treated (e.g., neurologic deficit, kyphosis > 30º, translation > 4 mm, and/or interspinous process widening) Have canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level(s) to be treated Have a bleeding disorder, including coagulopathy Have severe cardiopulmonary deficiencies Have an active systemic or local infection Are currently being treated for cancer or HIV Have a known allergy to acrylics (e.g., methyl methacrylate) Subject is currently an alcohol, solvent or drug abuser Female patients who are pregnant or nursing, or of childbearing potential not using a reliable contraceptive method Are involved in medical litigation Are prisoners Have participated in another investigational study within 30 days prior to inclusion