Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs

Inclusion Criteria

• •1. Identified as an appropriate candidate for BKP and should have made the choice to have the procedure.
• •2. Must be Medicare Eligible (At least 65 years of age or otherwise eligible).
• •3. Must have one to three target VCFs, located between T5 and L5, which are due to underlying primary or secondary osteoporosis or cancer.
• •4. Cancer patients should not have had a change in chemotherapy regimen within the last month, nor should they have a planned change within the next month from time of enrollment, with the exception of changes in dose.
• •5. All VCFs to be treated must have clinical pain symptoms (pain on palpation/percussion over the fractured vertebral body) that correlate with radiographic findings as follows:
• •1. Height change: An acute (≤ four 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 one or more grades by the Genant criteria20, OR
• •2. Positive MRI or bone scan: VB shows hyperintense signal on STIR sequence MRI, or target VB is positive on radionuclide bone scan.
• •6. All VCFs to be treated must have an estimated fracture age of four months or less.
• •7. Treatment of all target VCFs must be technically feasible and clinically appropriate for balloon kyphoplasty.
• •8. Pre-treatment back pain by numerical rating scale (NRS) score must be ≥ 7 (0-10 scale) and refractory to non-surgical management.
• •9. Pre-treatment Oswestry Disability Index must be ≥30 (0 - 100 scale).
• •10. Must have life expectancy of ≥ 12 months.
• •11. Must declare availability for all study visits.
• •12. Must be able to understand the risks and benefits of participating in the study and be willing to provide written informed consent.
• •13. Must have the mental capacity necessary to comply with protocol requirements for the 12- month duration of study.