Evidence map›Paper›PMID 27544377›Full record

ArticleLancet (London, England)2016

Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial.

William Clark, Paul Bird, Peter Gonski, Terrence H Diamond, Peter Smerdely, H Patrick McNeil, Glen Schlaphoff, Carl Bryant, Elizabeth Barnes, Val Gebski

Erratum issued Registry-linked trialAbstract readComment
PubMed Publisher
In one paragraph

Article in Lancet (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01482793 (A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.), which is not on this map. Cited by 200 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
200citing papers in PubMed, 14 pooled it
44.3field-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.

NCT01482793 nacompletednot on this map

A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.

TypeinterventionalSponsorOptimus Clinical ResearchRan2011 to 2015Enrolled120ConditionsVertebral Compression Fractures, Osteoporotic Vertebral Compression Fractures, Acute Vertebral FracturesArmsVertebroplasty
3 · Its place in the literature

Who cites it

200 citing papers in PubMed, 14 syntheses or guidelines pooled it, 432 citations in OpenAlex.

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  8. A review of trauma and orthopaedic randomised clinical trials published in high-impact general medical journals.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2022
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  10. Clinical and radiological subsequent fractures after vertebral augmentation for treating osteoporotic vertebral compression fractures: a 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 · 2020
    Pooled it
  11. Percutaneous cement augmentation in the treatment of osteoporotic vertebral fractures (OVFs) in the elderly: a systematic review.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
    Pooled it
  12. Percutaneous vertebroplasty versus non-operative treatment for osteoporotic vertebral compression fractures: a meta-analysis of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Pooled it
  13. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  14. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
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140 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

William ClarkDepartment of Radiology, St George Private Hospital, Kogarah, NSW, Australia. Electronic address: williamxrayclark@bigpond.com.
Paul BirdSt George and Sutherland Clinical School, University of New South Wales, Sydney, NSW, Australia.
Peter GonskiSchool of Public Health & Community Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Aged Care, Sutherland Hospital, Caringbah, NSW, Australia.
Terrence H DiamondSt George and Sutherland Clinical School, University of New South Wales, Sydney, NSW, Australia; Department of Endocrinology, St George Hospital, Kogarah, NSW, Australia.
Peter SmerdelySchool of Public Health & Community Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Aged Care, St George Hospital, Kogarah, NSW, Australia.
H Patrick McNeilFaculty of Medicine and Health Sciences, Macquarie University, Sydney, NSW, Australia.
Glen SchlaphoffSouth Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia; Department of Interventional Radiology, Liverpool Hospital, Liverpool, NSW, Australia.
Carl BryantDepartment of Radiology, St George Private Hospital, Kogarah, NSW, Australia.
Elizabeth BarnesNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Val GebskiNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
St George Hospital · AUSutherland Hospital · AUMacquarie University · AUNational Health and Medical Research Council · AUSouth Western Sydney Local Health District · AUUniversity of Sydney · AU

Funding

6 · The paper itself

Abstract

backgroundWe hypothesised that vertebroplasty provides effective analgesia for patients with poorly controlled pain and osteoporotic spinal fractures of less than 6 weeks' duration. The effectiveness of vertebroplasty, using an adequate vertebral fill technique, in fractures of less than 6 weeks' duration has not been specifically assessed by previously published masked trials.

methodsThis was a multicentre, randomised, double-blind, placebo-controlled trial of vertebroplasty in four hospitals in Sydney, Australia. We recruited patients with one or two osteoporotic vertebral fractures of less than 6 weeks' duration and Numeric Rated Scale (NRS) back pain greater than or equal to 7 out of 10. We used an automated telephone randomisation service provided by the National Health and Medical Research Council to assign patients (1:1; stratified according to age, degree of vertebral compression, trauma, corticosteroid use, and hospital) to either vertebroplasty or placebo, immediately before the procedure. Patients received conscious sedation. Vertebroplasty was done with the adequate vertebral fill technique and the placebo procedure with simulated vertebroplasty. Follow-up was for 6 months. Outcome assessors and patients were masked to treatment allocation. The primary outcome was the proportion of patients with NRS pain below 4 out of 10 at 14 days post-intervention in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01482793.

findingsBetween Nov 4, 2011, and Dec 5, 2014, 120 patients were enrolled. 61 patients were randomly assigned to vertebroplasty and 59 to placebo. 24 (44%) patients in the vertebroplasty group and 12 (21%) in the control group had an NRS pain score below 4 out of 10 at 14 days (between-group difference 23 percentage points, 95% CI 6-39; p=0·011). Three patients in each group died from causes judged unrelated to the procedure. There were two serious adverse events in each group, related to the procedure (vertebroplasty group) and the fracture (control group).

interpretationVertebroplasty is superior to placebo intervention for pain reduction in patients with acute osteoporotic spinal fractures of less than 6 weeks' in duration. These findings will allow patients with acute painful fractures to have an additional means of pain management that is known to be effective.

fundingEducation grant from CareFusion Corporation.

Indexed as

Double-Blind MethodOsteoporotic FracturesFractures, CompressionHumansPain MeasurementTreatment OutcomeVertebroplasty

Identifiers

PMID27544377
OpenAlexW2518383310

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.