Wang Dongliang, Cang Dingwei, Wu Ya, Wang Siqing
Department of Spinal Surgery, Yancheng NO.1 People's Hospital, Jiang Su, China.
Medicine (Baltimore). 2020 Jul 2;99(27):e20770. doi: 10.1097/MD.0000000000020770.
Osteoporosis and related complications have been increasing with the aging population. Osteoporotic vertebral compression fractures (OVCFs) are the most common among all osteoporotic fractures. The purpose of this study was performed to compare the efficiency and safety of vertebroplasty versus conservative treatment for acute OVCFs.
The conduct of this study followed the Declaration of Helsinki principles and the reporting of this study adhered to the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials. Written informed consent was obtained from every participant. Participants were randomly assigned (1:1) to receive either vertebroplasty or control group. The primary outcome was pain relief at 1 month and 1 year, measured with a Visual Analogue Scale score. The secondary outcomes were Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications.
We hypothesize that vertebroplasty will provide a rapid decrease of pain and an early return to daily life activities compared with the control group.
This study protocol was registered in Research Registry (researchregistry5624).
随着人口老龄化，骨质疏松症及相关并发症的发生率一直在上升。骨质疏松性椎体压缩骨折（OVCFs）是所有骨质疏松性骨折中最常见的。本研究旨在比较椎体成形术与保守治疗急性OVCFs的有效性和安全性。
本研究遵循赫尔辛基宣言原则，研究报告遵循随机对照试验的报告统一标准指南。获得了每位参与者的书面知情同意书。参与者被随机分配（1:1）接受椎体成形术或对照组治疗。主要结局是1个月和1年时的疼痛缓解情况，采用视觉模拟量表评分进行测量。次要结局包括罗兰-莫里斯残疾问卷、简表评分、欧洲五维生活质量量表以及术后并发症。
我们假设与对照组相比，椎体成形术将使疼痛迅速减轻，并能使患者早日恢复日常生活活动。
本研究方案已在研究注册库（researchregistry5624）注册。
