Safety and Efficacy of Percutaneous Vertebroplasty for Osteoporotic Vertebral Compression Fractures: A Multicenter Retrospective Study in Japan.

Purpose: Bone cement enhancement by percutaneous vertebroplasty (PVP) for the treatment of osteoporotic vertebral compression fractures remains unapproved, as it has not been fully evaluated in Japan. The current multicenter study was conducted in Japan to verify the safety and efficacy of PVP in patients with painful osteoporotic vertebral fractures. Material and Methods: In this retrospective study, we referred to previous studies to evaluate the non-inferiority of PVP to balloon kyphoplasty (BKP). We reviewed consecutive patient data from April 2017 to March 2018 from four institutions based on the medical records of the intervention. We statistically investigated the adverse events due to cement leakage or other factors associated with PVP, and new vertebral compression fractures after PVP were evaluated for safety, pain relief, and gait improvement. Results: This study included 485 patients; most of whom were in the middle- to oldest- age groups (mean age, 81.4 years). No serious adverse events were reported in patients available for safety evaluation (n = 485). Cement leakage and new vertebral compression fractures occurred in 35.7% and 18.6% (26.2%-38.4% and 8.9%-20.7%) of the patients undergoing PVP, respectively, both of which were also judged to be equivalent to those of BKP. The pain score improved in those undergoing PVP, and this improvement was maintained during a one-year follow-up. Of the 206 patients who had difficulty walking at baseline, 156 had restored walking at discharge. Conclusions: PVP was shown to be a safe and effective treatment, even in elderly patients with painful osteoporotic vertebral fractures.