Evidence map›Paper›PMID 25873274›Full record

Trial reportTrials2015

Vertebroplasty for acute painful osteoporotic fractures (VAPOUR): study protocol for a randomized controlled trial.

William Clark, Paul Bird, Terrence Diamond, Peter Gonski

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01482793 (A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 11% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

William ClarkDepartment of Interventional Radiology, St George Private Hospital, Kogarah, NSW, Australia. williamxrayclark@bigpond.com.
Paul BirdUniversity of NSW, Sydney, NSW, Australia. PBird@optimusresearch.com.au.
Terrence DiamondUniversity of NSW, Sydney, NSW, Australia. Terry.Diamond@sesiahs.health.nsw.gov.au.
Peter GonskiUniversity of NSW, Sydney, NSW, Australia. peter.gonski@sesiahs.health.nsw.gov.au.
New South Wales Department of Health · AUSt George Hospital · AUUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWith increasing human longevity there is increasing prevalence of osteoporosis and of osteoporotic vertebral fractures. Most vertebral fractures do not require medical therapy for pain, but a minority are associated with severe pain and disability. Vertebroplasty has been used increasingly for painful acute osteoporotic fractures. The best available evidence for vertebroplasty is provided by two placebo controlled trials which showed no significant clinical benefit of vertebroplasty over placebo. These were not acute fracture trials with the majority of fractures in both trials being well beyond the acute time frame of 6 weeks. There is evidence from an open label randomized controlled trial of vertebroplasty versus conservative therapy in acute fractures suggesting clinical efficacy in acute vertebral fractures.

methodsThis is a blinded trial of Vertebroplasty for Acute Painful Osteoporotic fractURes - the VAPOUR trial. Patients greater than 60 years in age with new severe onset of back pain and osteoporotic vertebral fractures of less than 6 weeks duration will be enrolled. They will be randomized to receive either vertebroplasty or a placebo procedure. Data regarding pain, disability, and quality of life will be collected over a 6-month period. The enrolled patients and the outcome assessors will remain blinded for the duration of the trial. DISCUSSION: The VAPOUR trial will apply similar methodology to the previous blinded trials but in a patient group with exclusively acute fractures and the most severe pain.

trial registrationClinicalTrials.gov trial identifier: NCT01482793 registered on 28 November 2011.

Indexed as

VertebroplastyAcute PainAgedBack PainClinical ProtocolsDiagnostic ImagingDisability EvaluationFemaleHumansMaleMiddle AgedNew South WalesOsteoporotic FracturesPain MeasurementQuality of LifeResearch Design

Identifiers

PMID25873274
PMCPMC4399105
OpenAlexW1963922467

What OpenQuestion holds

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LicenceCC BY
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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.