Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysisBMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d3952 (Published 12 July 2011) Cite this as: BMJ 2011;343:d3952
- 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
- 1Department of Clinical Epidemiology, Cabrini Hospital, and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Victoria, Australia
- 2Department of Radiology, Mayo Clinic College of Medicine, MN, USA
- 3Center for Biomedical Statistics, Department of Radiology, University of Washington, USA
- 4Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, USA
- 5Public Health Innovation, School of Health and Social Development, Deakin University, Victoria, Australia
- 6Department of Biostatistics, University of Washington, USA
- Correspondence to: R Buchbinder, Suite 41, Cabrini Medical Centre, 183 Wattletree Road, Malvern Victoria 3144, Australia
- Accepted 10 May 2011
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.
Contributors: RB and DFK planned the work. MPS carried out the analysis and MPS and RB drafted the manuscript. All authors contributed to the design of the analysis, interpretation of findings, and writing of the final manuscript. RB is the guarantor.
Funding: RHO is supported in part by an Australian National Health and Medical Research Council (NHMRC) population health career development award and RB is supported in part by an NHMRC practitioner fellowship.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: RHO is supported in part by an Australian National Health and Medical Research Council (NHMRC) population health career development award and RB is supported in part by an NHMRC practitioner fellowship; DFK has received research support from Stryker and ArthroCare and is a consultant for CareFusion, JGJ has received an honorarium for lecturing at a course sponsored by Synthes in 2010, is on the GE Healthcare comparative effectiveness advisory board, is a consultant to HealthHelp, and is cofounder and patent holder of PhysioSonics; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Not required.
Data sharing: No additional data available.
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