Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors

A Prospective, Multicenter Clinical Study to Evaluate the Clinical Outcomes of Targeted Radiofrequency Ablation and Vertebral Augmentation to Treat Painful Metastatic Vertebral Body Tumor(s)

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