60 - Outcomes of SpineJack® Implant–Assisted Vertebral Augmentation in the Management of Spinal Compression Fractures

Purpose: To evaluate outcomes of vertebral body fracture (VCF) management with SpineJack kyphoplasty, including pain control, performance status, opioid use, and overall survival (OS) with or without radiofrequency ablation (RFA).

Materials and Methods: 64 adult kyphoplasty patients from 2019-2025 undergoing a total of 77 SpineJack implantations inserted at 9 thoracolumbar levels for treatment of VCFs were retrospectively analyzed at a single center. 42 patients (66%) had pathologic fractures from malignancy, and 36 (57%) also received concurrent RFA. Outcomes included numerical rating system pain score (NRS), morphine milligram equivalents (MME), eastern cooperative oncology group performance status score (ECOG), and overall survival post-kyphoplasty (OS). There was an average follow-up period of 2 weeks post-kyphoplasty.

Results: Sixty-four patients were included (RFA 37; no RFA 27). Pain improved substantially at early follow-up: mean NRS decreased from 7.43 to 3.86 (Δ −3.57); paired Wilcoxon p < 0.0001 (n = 63). In an ANCOVA adjusting for baseline NRS, RFA was not associated with additional early pain reduction (β = 0.14; 95% CI −1.47 to 1.76; p = 0.863). ECOG performance status showed no significant overall change (median 2→2; Wilcoxon p = 0.446; n = 43) and did not differ by RFA on post-procedure comparison (Mann–Whitney p = 0.809). Opioid utilization (MME) showed heterogeneous temporal effects. Relative to baseline, MME was unchanged immediately (median 60.0→66.8; Δ +10.2; p = 0.252; n = 64) but decreased at 1 month (60.0→30.0; Δ −30.0; p = 0.0003; n = 58) and 3 months (52.5→0.0; Δ −30.0; p = 0.0053; n = 46). A Friedman test across immediate/1-/3-month timepoints was significant (χ² = 24.47; p < 0.0001; n = 44). In log-linear models adjusting for baseline MME, RFA was not associated with immediate post-procedure MME (β = 0.306; 95% CI −0.249 to 0.860; p = 0.280), but was associated with higher MME at 1 month (β = 2.120; 95% CI 1.135 to 3.106; p < 0.0001; ≈ +733.5%) and at 3 months (β = 2.896; 95% CI 1.961 to 3.832; p < 0.0001; ≈ +1710.8%). Median overall survival by reverse Kaplan–Meier was 21.2 months. No significant intraoperative complications were reported.

Conclusion: Vertebral kyphoplasty with SpineJack was associated with significant improvements in patient pain and reductions in opioid pain management requirements. Concurrent RFA was not associated with independent improvements in pain outcomes and was associated with a higher post-procedure opioid use. The findings suggest that vertebral kyphoplasty with SpineJack remains an effective treatment option for patients with VCFs.