Center for Spine Surgery & Research, Sygehus Lillebaelt, Kolding Sygehus, Sygehusvej 24, Kolding, 6000, Denmark.
Department of Regional Health Research, Faculty of Health Services, University of Southern Denmark, Odense, Denmark.
J Orthop Surg Res. 2024 Nov 30;19(1):813. doi: 10.1186/s13018-024-05301-x.
One in three women and one in five men over the age of 50 will experience an osteoporotic fracture. Vertebral fractures can be very painful, affect patients' daily function, and in severe cases require hospitalization. Traditionally, fracture pain is treated conservatively with analgesics, and bracing. Vertebral augmentation, also known as vertebroplasty, has been used during the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for its efficacy is weak. We describe a double-blind randomized sham-controlled clinical trial to assess the impact of vertebroplasty on self-reported clinical outcomes in patients with painful osteoporotic vertebral compression fractures and vertebral oedema.
Two hundred and forty patients with painful osteoporotic vertebral fractures and MRI verified oedema will be randomized in a prospective, double-blind, single-center, clinical trial to either vertebroplasty or a sham procedure, with the possibility of crossover 12 weeks after randomization and operation. The primary outcome will be difference in self-reported pain 12 weeks after treatment between the vertebroplasty and sham group. Secondary outcomes will be patient-reported disability, health-related quality of life, societal costs of treatment and complications. Analysis will be based on intention-to-treat. Repeated measures ANCOVA with baseline ODI, Numerical Pain Rating Scale, EQ-5D-5 L, and number of levels involved as co-variates will be performed.
With an aging population, the prevalence of osteoporosis and related complications such as vertebral compression fractures is expected to increase. Therefore, there is a growing need for evidence-based fracture treatments. This study fills a gap in the evidence base for treatment of painful osteoporotic vertebral fractures and will likely influence future treatment guidelines.
The study has been evaluated and approved by the Regional Committees on Health Research for Southern Denmark October 9 2023 (Projekt-ID S-20230058) and the Danish Data Protection Agency 23/40,938. The protocol has been registered at ClinicalTrials.gov with trial registration number NCT06141187 November 21, 2023.
三分之一的女性和五分之一的 50 岁以上男性会经历骨质疏松性骨折。椎体骨折会非常疼痛，影响患者的日常功能，在严重的情况下需要住院治疗。传统上，骨折疼痛采用镇痛药和支具进行保守治疗。椎体增强术，也称为椎体成形术，作为治疗椎体压缩性骨折的微创治疗选择，已经使用了三十年，但疗效的证据基础很薄弱。我们描述了一项双盲随机假对照临床试验，以评估椎体成形术对有疼痛性骨质疏松性椎体压缩性骨折和椎体水肿的患者的自我报告临床结果的影响。
将 240 名患有疼痛性骨质疏松性椎体骨折和 MRI 证实的水肿的患者随机分为椎体成形术组或假手术组，在随机分组和手术后 12 周可能进行交叉。主要结局是治疗 12 周后椎体成形术组和假手术组之间自我报告疼痛的差异。次要结局将是患者报告的残疾、健康相关生活质量、治疗的社会成本和并发症。分析将基于意向治疗。将使用重复测量协方差分析，以基线 ODI、数字疼痛评分量表、EQ-5D-5 L 和受累水平数作为协变量。
随着人口老龄化，骨质疏松症及其相关并发症（如椎体压缩性骨折）的患病率预计会增加。因此，对基于证据的骨折治疗方法的需求不断增加。这项研究填补了治疗疼痛性骨质疏松性椎体骨折的证据基础的空白，并可能影响未来的治疗指南。
该研究已由南丹麦地区健康研究委员会于 2023 年 10 月 9 日（项目 ID S-20230058）和丹麦数据保护局 23/40,938 进行了评估和批准。该方案已在 ClinicalTrials.gov 上注册，试验注册号为 NCT06141187，于 2023 年 11 月 21 日注册。
