EFFECTIVENESS AND SAFETY OF SPINEJACK SYSTEM IN THE MANAGEMENT OF VERTEBRAL FRAGILITY FRACTURES: A SYSTEMATIC REVIEW

Abstract

Introduction: The SpineJackⓇ (SJ) system received FDA clearance in 2018, therefore this device is currently available to perform kyphoplasty in osteoporotic vertebral fractures. This study aims to assess the outcome of the SJ system in the management of vertebral fragility fractures (VFFs). Evidence Acquisition and Synthesis: OVID-MEDLINEⓇ, EMBASE, Cochrane Library, SCOPUS, Springer Link, Web of Science, Google Scholar and PubMed were searched from January 2015 to November 2021 to identify relevant studies. The methodological qualities of the studies were evaluated, and relevant data were extracted. Seven clinical trials, recruiting 644 patients with 690 VFFs were included. Although PVP, balloon kyphoplast (BKP) and SJ showed comparable effectiveness in back pain relief in patients with VFFs, SJ showed a faster and higher pain relief and a better quality of life, compared with the other two augmentation techniques. Moreover, patients treated with SJ, compared with PVP and BKP, showed a better vertebral body height (VBH) restoration and kyphotic correction; these findings were confirmed also at long-term follow-up. Asymptomatic cement leakage and adjacent level fractures (ALFs) were observed in patients treated with SJ, but with a lower incidence compared with PVP and BKP. Conclusions: This systematic review shows that SJ has an excellent risk/benefit profile and is more effective than the other augmentation techniques in VBH restoration and kyphotic correction. These findings correlate with a better postoperative quality of life.