Difficulty Enrolling

To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.

Inclusion Criteria:

• One to 2 painful vertebrae (T1-L5) with evidence of osteolytic metastatic lesion with known primary histology with pathologic fracture(s) at index vertebra by MRI
• Pain score ≥ 4 on the numerical rating pain scale
• Life expectancy of ≥ 6 months

Exclusion Criteria:

• Primary tumors of the bone at index vertebra
• Benign tumors of the bone at index vertebra
• Osteoblastic tumors at index vertebra
• Index vertebra with more than one (1) pedicle involved
• Epidural extension of tumor within 5 mm of the spinal cord or without sufficient room for thermal protective maneuvers
• Spinal cord compression or canal compromise requiring decompression
• Radiation therapy is planned to be started on the index vertebra within 4 weeks post procedure
• Radiation therapy was performed on the index vertebra within 2 months before enrollment
• Major surgery of the spine was performed within 3 months before enrollment
• Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty
• Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra