Abstract

RF-TVA employs a novel system containing a steerable osteotome for site-specific cavity creation and radiofrequency (RF) modulation of cement viscosity delivered using a hydraulic delivery system. We report a prospective study of patients with acute osteoporotic vertebral compression fractures (VCF) with this system. Between May 2009 and January 2011, 20 patients with 1-3 painful VCFs (confirmed by MRI and pain concordant with index level) who were to receive kyphoplasty treatment were enrolled. Inclusion criteria included age between 50-90, Visual Analogue Pain (VAS) score >4, a moderate (21-40%) or greater Oswestry Disability Index (ODI) score, and 20-90% vertebral compression. VAS and ODI scores were recorded pre-procedure, at discharge, one week, one month, and three months after the procedure. ODI scores were recorded at the same time points except at discharge. Each procedure was performed using this Vertebral Augmentation System. A trocar was placed via a unipedicular approach. . Using a remotely controlled delivery system RF energy was applied tothe PMMA cement as it passed into the delivery cannula. Average patient age was 79.7 ±9.85 years. The mean percentage of collapse was 28 ±13. %. A majority of patients had associated diseases, the most common ones being hypertension (N=14) and coronary artery diseases (N=9). All surgeries were performed within 42 days (av. 13 days) of the patient's reported date of injury. The average procedure time was 18.6 ± 8.95 minutes. No procedure related complications were encountered. No patients required bilateral procedures. The improvement in mean VAS scores from pre-procedure to discharge was 3.4 (p<0.0001). At 1 week, 1 month and 3 months, the improvement in mean VAS score was 3. After three months, the improvement in average ODI scores was significant (34.14%, p < 0.0001). Radiofrequency targeted vertebral augmentation (RF-TVA) is a safe and effective method for treatment of vertebral compression fractures. The use of RF energy, to warm cement immediately prior to entering the patient, results in the unique combination of consistently high viscosity cement useable over an extended working time.

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