title: Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial.
abstract: We hypothesised that vertebroplasty provides effective analgesia for patients with poorly controlled pain and osteoporotic spinal fractures of less than 6 weeks' duration. The effectiveness of vertebroplasty, using an adequate vertebral fill technique, in fractures of less than 6 weeks' duration has not been specifically assessed by previously published masked trials.
  
  
  
  This was a multicentre, randomised, double-blind, placebo-controlled trial of vertebroplasty in four hospitals in Sydney, Australia. We recruited patients with one or two osteoporotic vertebral fractures of less than 6 weeks' duration and Numeric Rated Scale (NRS) back pain greater than or equal to 7 out of 10. We used an automated telephone randomisation service provided by the National Health and Medical Research Council to assign patients (1:1; stratified according to age, degree of vertebral compression, trauma, corticosteroid use, and hospital) to either vertebroplasty or placebo, immediately before the procedure. Patients received conscious sedation. Vertebroplasty was done with the adequate vertebral fill technique and the placebo procedure with simulated vertebroplasty. Follow-up was for 6 months. Outcome assessors and patients were masked to treatment allocation. The primary outcome was the proportion of patients with NRS pain below 4 out of 10 at 14 days post-intervention in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01482793.
  
  
  
  Between Nov 4, 2011, and Dec 5, 2014, 120 patients were enrolled. 61 patients were randomly assigned to vertebroplasty and 59 to placebo. 24 (44%) patients in the vertebroplasty group and 12 (21%) in the control group had an NRS pain score below 4 out of 10 at 14 days (between-group difference 23 percentage points, 95% CI 6-39; p=0·011). Three patients in each group died from causes judged unrelated to the procedure. There were two serious adverse events in each group, related to the procedure (vertebroplasty group) and the fracture (control group).
  
  
  
  Vertebroplasty is superior to placebo intervention for pain reduction in patients with acute osteoporotic spinal fractures of less than 6 weeks' in duration. These findings will allow patients with acute painful fractures to have an additional means of pain management that is known to be effective.
  
  
  
  Education grant from CareFusion Corporation.
authors.affiliation: Department of Radiology, St George Private Hospital, Kogarah, NSW, Australia. Electronic address: williamxrayclark@bigpond.com.
authors.forename: William
authors.initials: W
authors.lastname: Clark
authors.affiliation: St George and Sutherland Clinical School, University of New South Wales, Sydney, NSW, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Bird
authors.affiliation: School of Public Health & Community Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Aged Care, Sutherland Hospital, Caringbah, NSW, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Gonski
authors.affiliation: St George and Sutherland Clinical School, University of New South Wales, Sydney, NSW, Australia; Department of Endocrinology, St George Hospital, Kogarah, NSW, Australia.
authors.forename: Terrence H
authors.initials: TH
authors.lastname: Diamond
authors.affiliation: School of Public Health & Community Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Aged Care, St George Hospital, Kogarah, NSW, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Smerdely
authors.affiliation: Faculty of Medicine and Health Sciences, Macquarie University, Sydney, NSW, Australia.
authors.forename: H Patrick
authors.initials: HP
authors.lastname: McNeil
authors.affiliation: South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia; Department of Interventional Radiology, Liverpool Hospital, Liverpool, NSW, Australia.
authors.forename: Glen
authors.initials: G
authors.lastname: Schlaphoff
authors.affiliation: Department of Radiology, St George Private Hospital, Kogarah, NSW, Australia.
authors.forename: Carl
authors.initials: C
authors.lastname: Bryant
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Barnes
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
authors.forename: Val
authors.initials: V
authors.lastname: Gebski
mesh_terms: D004311:Double-Blind Method; D050815:Fractures, Compression; D006801:Humans; D058866:Osteoporotic Fractures; D010147:Pain Measurement; D016896:Treatment Outcome; D054854:Vertebroplasty