Klazen C A H, Verhaar H J J, Lampmann L E H, Juttmann J R, Blonk M C, Jansen F H, Tielbeek A V, Schoemaker M C, Buskens E, van der Graaf Y, Janssens X, Fransen H, van Everdingen K J, Muller A F, Mali W P Th M, Lohle P N M
Department of Radiology, St, Elisabeth Hospital Tilburg, The Netherlands.
Trials. 2007 Oct 31;8:33. doi: 10.1186/1745-6215-8-33.
The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is gaining popularity as a new treatment option. Many prospective and retrospective studies have reported on the effectiveness and safety of PV, but no large randomized controlled trial (RCT) has been published.
To estimate cost-effectiveness of PV compared to conservative therapy in terms of: pain reduction, quality of life, complications, secondary fractures and mortality.
The VERTOS II study is designed as a prospective, multicenter RCT. Patients with a painful VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent are included and randomized for PV or conservative therapy. In total 200 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with standard questionnaires, addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score, quality of life and cost-effectiveness. Secondary fractures, necessary additional therapies and complications are recorded.
The VERTOS II study is the first methodologically sound RCT designed to assess the cost-effectiveness of PV compared to conservative therapy in patients with an acute osteoporotic VCF.
http://www.clinicaltrials.gov, NCT00232466.
骨质疏松性椎体压缩骨折（VCF）患者的标准治疗是保守治疗。经皮椎体成形术（PV）作为一种微创技术，作为一种新的治疗选择正越来越受欢迎。许多前瞻性和回顾性研究都报道了PV的有效性和安全性，但尚未发表大型随机对照试验（RCT）。
从减轻疼痛、生活质量、并发症、二次骨折和死亡率方面评估PV与保守治疗相比的成本效益。
VERTOS II研究设计为一项前瞻性、多中心RCT。纳入经磁共振成像显示有骨水肿的疼痛性VCF、局部背痛6周或更短时间、骨质减少且年龄在50岁及以上的患者，在获得知情同意后，随机分为PV组或保守治疗组。总共将招募200名患者。在1年期间定期进行随访，使用标准问卷，涉及：临床症状、止痛药物、视觉模拟量表（VAS）评分、生活质量和成本效益。记录二次骨折、必要的额外治疗和并发症。
VERTOS II研究是第一项设计合理的RCT，旨在评估PV与保守治疗相比在急性骨质疏松性VCF患者中的成本效益。
