Evidence map›Paper›PMID 21750078›Full record

SynthesisBMJ (Clinical research ed.)2011

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

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

Open access · hybridAbstract readEvaluation StudyMeta-Analysis
In one paragraph

Synthesis in BMJ (Clinical research ed.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 8 pooled it
15.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 8 syntheses or guidelines pooled it, 122 citations in OpenAlex.

  1. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Single balloon versus double balloon bipedicular kyphoplasty: a systematic review and meta-analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2018
    Pooled it
  3. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Balloon kyphoplasty versus percutaneous vertebroplasty for treatment of osteoporotic vertebral compression fractures (OVCFs).Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2016
    Pooled it
  5. Is vertebroplasty a risk factor for subsequent vertebral fracture, meta-analysis of published evidence?Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015
    Pooled it
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  16. Early vertebroplasty within 3 weeks of fracture for acute painful vertebral osteoporotic fractures: subgroup analysis of the VAPOUR trial and review of the literature.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2020
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Margaret P StaplesDepartment of Clinical Epidemiology, Cabrini Hospital, and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Victoria, Australia.
David F Kallmes
Bryan A Comstock
Jeffrey G Jarvik
Richard H Osborne
Patrick J Heagerty
Rachelle Buchbinder
University of Washington · USAustralian Regenerative Medicine Institute · AUDeakin University · AUMayo Clinic in Arizona · US

Funding

INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
NCRR NIH HHS UL1 RR025014
6 · The paper itself

Abstract

objectiveTo 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).

designMeta-analysis of combined individual patient level data.

settingTwo multicentred randomised controlled trials of vertebroplasty; one based in Australia, the other in the United States.

participants209 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).

interventionPercutaneous vertebroplasty versus a placebo procedure.

main outcome measureScores for pain (0-10 scale) and function (modified, 23 item Roland-Morris disability questionnaire) at one month.

resultsFor 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.

conclusionsIndividual 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.

Indexed as

AgedBack PainFemaleFractures, CompressionHumansMaleMulticenter Studies as TopicPain MeasurementPersons with DisabilitiesRandomized Controlled Trials as TopicSpinal FracturesTreatment OutcomeVertebroplasty

Identifiers

PMID21750078
PMCPMC3133975
OpenAlexW2085293851

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.