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Meta-Analysis
. 2011 Jul 12:343:d3952.
doi: 10.1136/bmj.d3952.

Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis

Margaret P Staples  1 , David F Kallmes, Bryan A Comstock, Jeffrey G Jarvik, Richard H Osborne, Patrick J Heagerty, Rachelle Buchbinder
Affiliations
Meta-Analysis

Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis

Margaret P Staples et al. BMJ. .

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).

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.

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Conflict of interest statement

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.

Figures

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Mean (95% confidence intervals) scores for pain and disability (modified Roland-Morris disability questionnaire) at baseline, intermediate (two weeks/one week), and one month time points by treatment group for participants with recent onset pain (≤6 weeks) or pain of longer duration and for participants with mild to moderate or severe pain at baseline
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