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Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)

Authors: Cristina Firanescu, Paul NM Lohle, Jolanda de Vries, Caroline A Klazen, Job R Juttmann, William Clark, Willem Jan van Rooij, the VERTOS IV study group

Published in: Trials | Issue 1/2011

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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 a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs. The objective of this study is to compare pain relief after PV with a sham intervention in selected patients with an acute osteoporotic VCF using the same strict inclusion criteria as in VERTOS II. Secondary outcome measures are back pain related disability and quality of life.

Methods

The VERTOS IV study is a prospective, multicenter RCT with pain relief as primary endpoint. Patients with a painful osteoporotic 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 a sham intervention. In total 180 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with a standard Visual Analogue Scale (VAS) score for pain and pain medication. Necessary additional therapies and complications are recorded.

Discussion

The VERTOS IV study is a methodologically sound RCT designed to assess pain relief after PV compared to a sham intervention in patients with an acute osteoporotic VCF selected on strict inclusion criteria.

Trial registration

This study is registered at ClinicalTrials.gov., NCT01200277.
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Metadata
Title
A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)
Authors
Cristina Firanescu
Paul NM Lohle
Jolanda de Vries
Caroline A Klazen
Job R Juttmann
William Clark
Willem Jan van Rooij
the VERTOS IV study group
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-93

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