Journal Article

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

de Vries, Jolanda, van Rooij, Willem Jan, Juttmann, Job R, Klazen, Caroline A, Clark, William, Firanescu, Cristina, Lohle, Paul NM

2011

Overview

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 .

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Acute Disease / Analgesics - therapeutic use / Back pain / Back Pain - diagnosis / Back Pain - etiology / Back Pain - surgery / Biomedicine / Care and treatment / Clinical trials / Disability Evaluation / Edema / Fractures / Fractures, Compression - diagnosis / Fractures, Compression - etiology / Fractures, Compression - surgery / Health aspects / Health Sciences / Humans / Magnetic Resonance Imaging / Medicine / Medicine & Public Health / Middle Aged / Netherlands / Osteoporosis / Osteoporosis - complications / Osteoporosis - diagnosis / Pain Measurement / Patients / Polymethyl methacrylate / Prospective Studies / Quality of Life / Questionnaires / Research Design / Review boards / Spinal Fractures - diagnosis / Spinal Fractures - etiology / Spinal Fractures - surgery / Statistics for Life Sciences / Study Protocol / Treatment Outcome / Vertebroplasty