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

Inclusion Criteria

• Identified as an appropriate candidate for BKP and should have made the choice to have the procedure.
• Must be Medicare Eligible (At least 65 years of age or otherwise eligible).
• Must have one to three target VCFs, located between T5 and L5, which are due to underlying primary or secondary osteoporosis or cancer.
• 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.
• 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:
• 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
• 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 must have an estimated fracture age of four months or less.
• Treatment of all target VCFs must be technically feasible and clinically appropriate for balloon kyphoplasty.
• Pre-treatment back pain by numerical rating scale (NRS) score must be ≥ 7 (0-10 scale) and refractory to non-surgical management.
• Pre-treatment Oswestry Disability Index must be ≥30 (0 - 100 scale).
• Must have life expectancy of ≥ 12 months.
• Must declare availability for all study visits.
• Must be able to understand the risks and benefits of participating in the study and be willing to provide written informed consent.
• Must have the mental capacity necessary to comply with protocol requirements for the 12- month duration of study.

Exclusion Criteria

• Vertebral body morphology or fracture configuration contraindicative of balloon kyphoplasty.
• VCFs due to high-energy trauma.
• Asymptomatic VCFs or prophylactic treatment of non-fractured vertebral bodies.
• VCFs accompanied at the same site by primary tumors of the bone (e.g., osteosarcoma), solitary plasmacytoma or osteoblastic tumors.
• Platelet count of four months.
• VCF accompanied by objective evidence of secondary radiculopathy or neurologic compromise.
• VCFs with the need for spinal surgery beyond balloon kyphoplasty.
• Spinal cord compression or canal compromise requiring decompression.
• Significant clinical comorbidity that may either contra-indicate surgery or interfere with long-term data collection or follow-up.
• Pre-existing conditions contrary to balloon kyphoplasty such as:
• Allergy to any components (e.g., bone cement, contrast medium) of the balloon kyphoplasty device/procedure.
• Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection.
• Irreversible coagulopathy or bleeding disorder.
• Contraindications to both MRI and radionuclide bone scan.
• Concurrent participation in another clinical study.
• Pregnant or intending to become pregnant during the course of the study.