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

Staples, Margaret P., Kallmes, David F., Comstock, Bryan A., Jarvik, Jeffrey G., Osborne, Richard H., Heagerty, Patrick J. and Buchbinder, Rachelle 2011, Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials : meta-analysis, BMJ, vol. 343, pp. 1-11, doi: 10.1136/bmj.d3952.

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Title Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials : meta-analysis
Author(s) Staples, Margaret P.
Kallmes, David F.
Comstock, Bryan A.
Jarvik, Jeffrey G.
Osborne, Richard H.ORCID iD for Osborne, Richard H. orcid.org/0000-0002-9081-2699
Heagerty, Patrick J.
Buchbinder, Rachelle
Journal name BMJ
Volume number 343
Start page 1
End page 11
Total pages 11
Publisher B M J Group
Place of publication London, United Kingdom
Publication date 2011-07-12
ISSN 0959-535X
Summary 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.
Language eng
DOI 10.1136/bmj.d3952
Field of Research 111717 Primary Health Care
Socio Economic Objective 920205 Health Education and Promotion
HERDC Research category C1.1 Refereed article in a scholarly journal
Grant ID NHMRC 400391
Copyright notice ©2011, B M J Group
Persistent URL http://hdl.handle.net/10536/DRO/DU:30040982

Document type: Journal Article
Collections: Faculty of Health
School of Health and Social Development
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