BMJ 2011; 343:d3952 doi: 10.1136/bmj.d3952 (Published 12 July 2011)
Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis
- Margaret P Staples, biostatistician1,
- David F Kallmes, professor2,
- Bryan A Comstock, operations director3,
- Jeffrey G Jarvik, professor of radiology and neurological surgery and director4,
- Richard H Osborne, professor of public health and director5,
- Patrick J Heagerty, professor6,
- Rachelle Buchbinder, director and professor1
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).
Design Meta-analysis of combined individual patient level data.
Setting Two multicentred randomised controlled trials of vertebroplasty; one based in Australia, the other in the United States.
Participants 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).
Intervention Percutaneous vertebroplasty versus a placebo procedure.
Main outcome measure 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.