title: Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis.
abstract: OBJECTIVE
  To determine whether vertebroplasty is more effective than placebo for patients with pain of recent onset (≤ 6 weeks) or severe pain (score ≥ 8 on 0-10 numerical rating scale).
  
  
  METHODS
  Meta-analysis of combined individual patient level data.
  
  
  METHODS
  Two multicentred randomised controlled trials of vertebroplasty; one based in Australia, the other in the United States.
  
  
  METHODS
  209 participants (Australian trial n = 78, US trial n = 131) with at least one radiographically confirmed vertebral compression fracture. 57 (27%) participants had pain of recent onset (vertebroplasty n = 25, placebo n = 32) and 99 (47%) had severe pain at baseline (vertebroplasty n = 50, placebo n = 49).
  
  
  METHODS
  Percutaneous vertebroplasty versus a placebo procedure.
  
  
  METHODS
  Scores for pain (0-10 scale) and function (modified, 23 item Roland-Morris disability questionnaire) at one month.
  
  
  RESULTS
  For participants with pain of recent onset, between group differences in mean change scores at one month for pain and disability were 0.1 (95% confidence interval -1.4 to 1.6) and 0.2 (-3.0 to 3.4), respectively. For participants with severe pain at baseline, between group differences for pain and disability scores at one month were 0.3 (-0.8 to 1.5) and 1.4 (-1.2 to 3.9), respectively. At one month those in the vertebroplasty group were more likely to be using opioids.
  
  
  CONCLUSIONS
  Individual patient data meta-analysis from two blinded trials of vertebroplasty, powered for subgroup analyses, failed to show an advantage of vertebroplasty over placebo for participants with recent onset fracture or severe pain. These results do not support the hypothesis that selected subgroups would benefit from vertebroplasty.
authors.affiliation: Department of Clinical Epidemiology, Cabrini Hospital, and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Victoria, Australia.
authors.forename: Margaret P
authors.initials: MP
authors.lastname: Staples
authors.forename: David F
authors.initials: DF
authors.lastname: Kallmes
authors.forename: Bryan A
authors.initials: BA
authors.lastname: Comstock
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Jarvik
authors.forename: Richard H
authors.initials: RH
authors.lastname: Osborne
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Heagerty
authors.forename: Rachelle
authors.initials: R
authors.lastname: Buchbinder
mesh_terms: D000368:Aged; D001416:Back Pain / Q000601:surgery*; D006233:Persons with Disabilities; D005260:Female; D050815:Fractures, Compression / Q000601:surgery*; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D010147:Pain Measurement; D016032:Randomized Controlled Trials as Topic; D016103:Spinal Fractures / Q000601:surgery*; D016896:Treatment Outcome; D054854:Vertebroplasty / Q000379:methods*