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Randomised controlled trial
Conduct and reporting of a vertebroplasty trial warrants critical examination
  1. Rachelle Buchbinder1,
  2. David F Kallmes2,
  3. Jeffrey G Jarvik3,
  4. Richard A Deyo4
  1. 1 Monash Department of Clinical Epidemiology, Cabrini Institute and Department of Epidemiology and Preventive Medicine, Monash University, Malvern, Victoria, Australia
  2. 2 Mayo Clinic Minnesota, Rochester, Minnesota, USA
  3. 3 Oregon Health and Science University, Portland, Oregon, USA
  4. 4 Department of Radiology, University of Washington, Seattle, Washington, USA
  1. Correspondence to : Professor Jeffrey Jarvik, Department of Radiology, University of Washington, Seattle, Washington 98195-0005, USA; jarvikj{at}uw.edu

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Commentary on: Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 2016;388:1408–16.

Context

Percutaneous vertebroplasty was widely used in patients with symptomatic acute vertebral compression fractures until two placebo randomised controlled trials (RCTs) published in 2009 questioned its efficacy and safety.1 ,2 Consistent results across both trials indicated vertebroplasty was no more effective than placebo, while a combined individual patient metaanalysis failed to show an advantage for vertebroplasty for participants with fracture ≤6 weeks.3 Despite these data, some have suggested that there may be subgroups that would benefit from vertebroplasty.

Methods

VAPOUR was a multicentre participant-blinded and outcome assessor-blinded RCT assessing the efficacy of vertebroplasty versus placebo in 120 participants with acute (<6 weeks), severely painful vertebral compression fractures.4 The primary outcome was the proportion of …

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