S Lou1, X Shi1, X Zhang1, H Lyu2, Z Li2, Y Wang3. 1. Department of Spine Surgery, The First Affiliated Hospital of Harbin Medical University, No. 23 Youzheng Road, Harbin, 150001, Heilongjiang, People's Republic of China. 2. Department of Orthopedics, Chinese PLA General Hospital, Beijing, 100853, People's Republic of China. 3. Department of Spine Surgery, The First Affiliated Hospital of Harbin Medical University, No. 23 Youzheng Road, Harbin, 150001, Heilongjiang, People's Republic of China. wysgkql@163.com.
Abstract
PURPOSE: Osteoporotic vertebral compression fractures (OVCFs) are common in the elderly population and are often treated using percutaneous vertebroplasty (PVP). However, the effectiveness of PVP reported by various randomized controlled trials (RCTs) is inconclusive. This study aimed to analyze, from published literature, the efficacy and safety of PVP for OVCFs. METHODS: A search was conducted in Medline, EMBASE, and Cochrane Libraries since their respective inception on January 1, 2019, for RCTs of OVCFs treated with PVP compared with non-operative treatment. The primary outcomes were pain relief at 1 to 2 weeks, 1 to 3 months, and 6 to 12 months. The secondary outcome was the rate of occurrence of new vertebral fractures. Meta-analysis was performed using a random effect model. RESULTS: A total of 13 RCTs comprising 1624 patients were included. For the blinded studies, statistical differences were found between PVP and the sham injection group for the 3 primary outcomes in the subgroup of the Vertebroplasty for Acute Painful Osteoporotic fractURes (VAPOUR) trial. Although pain scores were similar between the PVP group and the sham injection group for the VAPOUR trial at each period, the effect size of PVP increased over time. For the open-label studies, PVP significantly reduced pain at all time points. The risk of new vertebral fractures was similar between the PVP groups and control groups. CONCLUSIONS: Application of PVP was effective and safe only in patients with acute OVCFs having persistent and severe pain. No benefits were recorded, among patients with older fractures or those bearing non-severe symptoms.
PURPOSE: Osteoporotic vertebral compression fractures (OVCFs) are common in the elderly population and are often treated using percutaneous vertebroplasty (PVP). However, the effectiveness of PVP reported by various randomized controlled trials (RCTs) is inconclusive. This study aimed to analyze, from published literature, the efficacy and safety of PVP for OVCFs. METHODS: A search was conducted in Medline, EMBASE, and Cochrane Libraries since their respective inception on January 1, 2019, for RCTs of OVCFs treated with PVP compared with non-operative treatment. The primary outcomes were pain relief at 1 to 2 weeks, 1 to 3 months, and 6 to 12 months. The secondary outcome was the rate of occurrence of new vertebral fractures. Meta-analysis was performed using a random effect model. RESULTS: A total of 13 RCTs comprising 1624 patients were included. For the blinded studies, statistical differences were found between PVP and the sham injection group for the 3 primary outcomes in the subgroup of the Vertebroplasty for Acute Painful Osteoporotic fractURes (VAPOUR) trial. Although pain scores were similar between the PVP group and the sham injection group for the VAPOUR trial at each period, the effect size of PVP increased over time. For the open-label studies, PVP significantly reduced pain at all time points. The risk of new vertebral fractures was similar between the PVP groups and control groups. CONCLUSIONS: Application of PVP was effective and safe only in patients with acute OVCFs having persistent and severe pain. No benefits were recorded, among patients with older fractures or those bearing non-severe symptoms.
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