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

Inclusion Criteria All subjects must meet all of the following criteria to be enrolled into the study: 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.) Pre-treatment back pain by numerical rating scale (NRS) score > 4 (0-10 scale) Pre-treatment Oswestry Disability Index >20 (0 - 100 scale) Subject states availability for all study visits Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent Subject has mental capacity to comply with the protocol requirements for 2-year duration of study Exclusion Criteria Subjects who meet any of the following conditions may not be enrolled into the study: VB morphology or configuration is such that either balloon kyphoplasty OR vertebroplasty is not technically feasible for the targeted VCFs Fracture due to high-energy trauma Suspected OR proven cancer inside index vertebral body. Note that patients with chemotherapy-related osteoporosis may be included. Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis) Any painful VCF with fracture age > 6 months Any objective evidence of neurologic compromise at baseline Previous balloon kyphoplasty or vertebroplasty for any VCF Spine stabilization beyond balloon kyphoplasty or vertebroplasty required for targeted VCFs Significant clinical comorbidity that may potentially interfere with long-term data collection or follow-up (e.g., dementia, severe comorbid illness) Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty, such as: Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Subjects on coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants. Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty or vertebroplasty. Note that in subjects with allergy to iodine-based contrast, other non-iodine contrast solutions may be used. Any evidence of VB or systemic infection Pregnant or child-bearing potential