Trial reportCardiovascular and interventional radiology2026
Radiofrequency Ablation for the Treatment of Bone Metastases: Results of the SPARTA Study.
Trial report in Cardiovascular and interventional radiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeThis study evaluated the safety and efficacy of radiofrequency ablation for the palliative treatment of bone metastases in the SPARTA study. MATERIALS AND
methodsThe 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.
resultsAmong 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.
conclusionThe 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.
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