KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures

Inclusion criteria

• ✓. Age \> 21
• ✓. 1 to 3 target VCFs meeting the following criteria:
• ✓. Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis
• ✓. All target VCFs are between T5 and L5
• ✓. All target VCFs to be treated show either: i. Height change: An acute (\< 6 month) change in VB height or morphology from a previous x-ray, CT or MRI, with height loss at the anterior, middle or posterior portion of the VB consistent with a worsening of 1 or more grades by the Genant criteria (17), OR ii. Positive MRI or bone scan: VB shows hyperintense signal on STIR sequence MRI or target VB is positive on radionuclide bone scan
• ✓. All VCFs to be treated have fracture age (time from pain onset to evaluation by the Investigator) of 6 months or less
• ✓. Back pain correlating with the location of at least one VCF
• ✓. Treatment of all target VCFs is technically feasible by and clinically appropriate for BOTH vertebroplasty and balloon kyphoplasty. (Team approach only: Both the vertebroplasty and balloon kyphoplasty physician have reviewed radiographic studies and agree to this prior to enrolling the subject in the study.)

Exclusion criteria