Abstract
Introduction: The efficacy of percutaneous vertebroplasty (PV) versus placebo and conservative treatment (CT) in patients with osteoporotic vertebral fractures (OVFs) has been debated in recent years. The aim of this study was to conduct an updated systematic review with a meta-analysis on the efficacy of randomized controlled trials (RCTs) comparing PV versus placebo and CT in pain relief, functionality and quality of life in patients with OVFs. Methods: A systematic search was conducted in PubMed, Web of Science, EMBASE, and CENTRAL, resulting in a total of 15 RCTs. The risk of bias was assessed using the Risk of Bias v.2 tool. A meta-analysis was performed using the weighted inverse variance method to analyze the standardized mean difference (SMD) in pain (VAS/NRS scales), functionality (RMDQ/ODI scales) and quality of life (QUALEFFO scale) in the short (<1 month), medium (1-6 months) and long terms (≥6 months). Heterogeneity was assessed using I(2) and τ(2). Subgroup analyses were performed according to the type of control, geographic region, number of institutions, fracture chronicity, and risk of bias. In addition, sensitivity (leave-one-out) and publication bias (funnel plots and Egger's tests) analyses were performed. Results: Overall, PV showed benefits over the combined control groups in pain relief in the short (SMD: -0.68; 95%CI: -1.28--0.07), medium (SMD: -0.63; 95%CI: -1.18--0.07), and long terms (SMD: -0.59; 95%CI: -1.02--0.15). No statistically significant differences were found in functionality and quality of life, although several trends toward significance were observed favoring PV. Subgroup analyses showed greater advantages of PV at several time intervals in acute (<8 weeks) OVFs, multicentric trials and studies with a low risk of bias. There were cues suggestive of potential publication bias in functionality, but not in pain or quality of life. Conclusions: PV shows significant benefits in pain relief, particularly in acute OVFs, but its efficacy in terms of functionality and quality of life remains unclear. These results support the use of PV in appropriately selected patients. However, given the high heterogeneity found, more controlled, multicenter trials are still required.