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Open Access 01-12-2007 | Study protocol

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

Authors: CAH Klazen, HJJ Verhaar, LEH Lampmann, JR Juttmann, MC Blonk, FH Jansen, AV Tielbeek, MC Schoemaker, E Buskens, Y van der Graaf, X Janssens, H Fransen, KJ van Everdingen, AF Muller, WPThM Mali, PNM Lohle

Published in: Trials | Issue 1/2007

Abstract

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.

Trial registration

http://www.clinicaltrials.gov, NCT00232466

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Title: 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
Authors: CAH Klazen
HJJ Verhaar
LEH Lampmann
JR Juttmann
MC Blonk
FH Jansen
AV Tielbeek
MC Schoemaker
E Buskens
Y van der Graaf
X Janssens
H Fransen
KJ van Everdingen
AF Muller
WPThM Mali
PNM Lohle
Publication date: 01-12-2007
Publisher: BioMed Central
Published in: Trials / Issue 1/2007
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/1745-6215-8-33

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Objective

Materials and methods

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Objective

Materials and methods

Conclusion

Trial registration

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