VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial

被引：51

作者：

Klazen, C. A. H. ^{[1
,11
,12
]}

Verhaar, H. J. J. ^{[2
]}

Lampmann, L. E. H. ^{[1
]}

Juttmann, J. R. ^{[3
]}

Blonk, M. C. ^{[4
]}

Jansen, F. H. ^{[5
]}

Tielbeek, A. V. ^{[5
]}

Schoemaker, M. C. ^{[1
]}

Buskens, E. ^{[6
]}

van der Graaf, Y. ^{[6
]}

Janssens, X. ^{[7
]}

Fransen, H. ^{[8
]}

van Everdingen, K. J. ^{[9
]}

Muller, A. F. ^{[10
]}

Mali, W. P. Th M. ^{[11
]}

Lohle, P. N. M. ^{[1
]}

机构：

[1] St Elisabeth Hosp Tilburg, Dept Radiol, Tilburg, Netherlands

[2] Univ Med Ctr Utrecht, Dept Geriatr Med, Utrecht, Netherlands

[3] St Elisabeth Hosp Tilburg, Dept Internal Med, Tilburg, Netherlands

[4] Catharina Hosp, Dept Internal Med, Eindhoven, Netherlands

[5] Catharina Hosp, Dept Radiol, Eindhoven, Netherlands

[6] Julius Ctr Hlth Sci & Primary Care, Dept Clin Epidemiol, Utrecht, Netherlands

[7] AZ St Lucas Hosp Gent, Dept Rheumatol, Ghent, Belgium

[8] AZ St Lucas Hosp Gent, Dept Radiol, Ghent, Belgium

[9] Diakonessenhuis Utrecht, Dept Radiol, Utrecht, Netherlands

[10] Diakonessenhuis Utrecht, Dept Internal Med, Utrecht, Netherlands

[11] Univ Med Ctr Utrecht, Dept Radiol, Utrecht, Netherlands

[12] Univ Groningen, Univ Med Ctr Groningen, Groningen, Netherlands

来源：

TRIALS | 2007年 / 8卷 / 1期

关键词：

D O I：

10.1186/1745-6215-8-33

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: 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. Objective: To estimate cost-effectiveness of PV compared to conservative therapy in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. Materials and methods: 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. Conclusion: 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.

引用

页数：5

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