Short-term clinical outcomes and safety of the SpineJack implant system for the treatment of pathological vertebral compression fractures in cancer patients: A retrospective analysis.

BACKGROUND

The SpineJack implant system is an FDA-approved treatment modality for vertebral compression fractures (VCFs) with reported clinical efficacy comparable to the gold-standard balloon kyphoplasty. Specifically, there is insufficient literature regarding the treatment and safety outcomes of the SpineJack when analyzing a specific subset of patients such as the cancer population.

METHODS

This is an institutional-level retrospective study at a cancer center on the SpineJack implant consisting of 67 cancer patients (mean age 64 ± 13 years) undergoing a total of 94 SpineJack implantations inserted at 15 thoracolumbar vertebral levels for the treatment of pathologic vertebral compression fractures. The primary outcome of the study was the change in pain score based on the Numeric Rating Scale (NRS) and the secondary outcome was the change in opioid requirement based on morphine milligram equivalents (MME). The average follow-up period was 2 weeks.

RESULTS

Post-procedure, a statistically significant decrease in pain severity was observed, with the mean pain score improving from 7.72 ± 2.29 points to 3.45 ± 2.55 points (p-value < 0.0001). Additionally, a reduction in opioid requirement was noted, with a decrease in MME from 66.42 ± 92.66 mg preoperatively to 43.1 ± 60.78 mg (p-value < 0.0001) postoperatively. There was a 1.5% (N = 1) incidence of adjacent level fracture (ALF) reported over an average of 2-week follow-up. The most common intraoperative complication reported was cement extravasation.

CONCLUSION

Overall, treatment of cancer patients with pathologic fractures using the SpineJack procedure resulted in remarkably decreased pain scores, overall decreased MME requirements, a significantly low incidence of ALF (s), and minor intraoperative complications without long-term consequences. The SpineJack procedure is a clinically effective, low-risk treatment option for cancer patients with symptomatic, pathologic VCFs.