Cardiovascular and interventional radiology · 2026
Radiofrequency Ablation for the Treatment of Bone Metastases: Results of the SPARTA Study.
СтатьяМногоцентровое исследованиеКлиническое исследованиеНазвание и аннотация: Перевод в очереди
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Muto Mario, Amato Francesco, Bellini Matteo, Manfrè Luigi, Piras Emanuele, Marcia Stefano, Marini Stefano, Iannaccone Tiziana, Lucarelli Francesco
Аннотация
PURPOSE: This study evaluated the safety and efficacy of radiofrequency ablation for the palliative treatment of bone metastases in the SPARTA study.
MATERIALS AND METHODS: The SPINERY® Radiofrequency Ablation (RFA) System Premarket Study (SPARTA) is a prospective, single-arm, multicenter clinical trial in Italy. Patients with metastatic bone tumors underwent RFA using SPINERY® between July 2022 and December 2023. The Brief Pain Inventory (BPI) for pain severity and the EQ-5D-5L questionnaire for quality of life (QoL) were assessed at baseline and at 1, 3, and 12 months post-procedure. Primary endpoints were achievement of a ≥ 2-point reduction in the 3-month BPI score, and completion of the procedure without device-related adverse events.
RESULTS: Among 52 enrolled patients (mean age 63.8 ± 11.2, 61.5% [32/52] female), RFA was performed in 51, followed by vertebroplasty in 78.4% (40/51), with 100% technical success and no device-related adverse events. Compared to baseline, mean BPI scores improved at 1 month (Δ- 3.3 ± 2.7, p < 0.001), 3 months (Δ- 4.2 ± 2.5, p < 0.001), and 12 months (Δ- 5.4 ± 2.7, p < 0.001). Mean EQ-5D-5L scores also improved at 1 month (Δ15.7 ± 17.6, p < 0.001), 3 months (Δ22.7 ± 17.1, p < 0.001), and 12 months (Δ33.3 ± 20.7, p < 0.001). There were 13 (25.5%) adverse events and 13 (25.5%) deaths that were disease-related, not device-related.
CONCLUSION: The SPARTA study demonstrates rapid and substantial pain relief within 1 month and improved QOL, supporting radiofrequency ablation, in combination with vertebroplasty when indicated, as a minimally invasive treatment for pain associated with bone metastases. LEVEL OF EVIDENCE 3: Prospective cohort study.
MATERIALS AND METHODS: The SPINERY® Radiofrequency Ablation (RFA) System Premarket Study (SPARTA) is a prospective, single-arm, multicenter clinical trial in Italy. Patients with metastatic bone tumors underwent RFA using SPINERY® between July 2022 and December 2023. The Brief Pain Inventory (BPI) for pain severity and the EQ-5D-5L questionnaire for quality of life (QoL) were assessed at baseline and at 1, 3, and 12 months post-procedure. Primary endpoints were achievement of a ≥ 2-point reduction in the 3-month BPI score, and completion of the procedure without device-related adverse events.
RESULTS: Among 52 enrolled patients (mean age 63.8 ± 11.2, 61.5% [32/52] female), RFA was performed in 51, followed by vertebroplasty in 78.4% (40/51), with 100% technical success and no device-related adverse events. Compared to baseline, mean BPI scores improved at 1 month (Δ- 3.3 ± 2.7, p < 0.001), 3 months (Δ- 4.2 ± 2.5, p < 0.001), and 12 months (Δ- 5.4 ± 2.7, p < 0.001). Mean EQ-5D-5L scores also improved at 1 month (Δ15.7 ± 17.6, p < 0.001), 3 months (Δ22.7 ± 17.1, p < 0.001), and 12 months (Δ33.3 ± 20.7, p < 0.001). There were 13 (25.5%) adverse events and 13 (25.5%) deaths that were disease-related, not device-related.
CONCLUSION: The SPARTA study demonstrates rapid and substantial pain relief within 1 month and improved QOL, supporting radiofrequency ablation, in combination with vertebroplasty when indicated, as a minimally invasive treatment for pain associated with bone metastases. LEVEL OF EVIDENCE 3: Prospective cohort study.