Evidence map›Paper›PMID 19657122›Full record

Trial reportThe New England journal of medicine2009

A randomized trial of vertebroplasty for osteoporotic spinal fractures.

David F Kallmes, Bryan A Comstock, Patrick J Heagerty, Judith A Turner, David J Wilson, Terry H Diamond, Richard Edwards, Leigh A Gray, Lydia Stout, Sara Owen and 5 more

Erratum issued 3 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2009. 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 3 registered trials, which are not on this map. Cited by 477 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
477citing papers in PubMed, 20 pooled it
131.4field-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.

NCT00068822 phase3completednot on this map

Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)

TypeinterventionalSponsorMayo ClinicRan2003 to 2009Enrolled131ConditionsSpinal Fractures, OsteoporosisArmsPercutaneous vertebroplasty, Sham vertebroplasty
NCT02370628 naterminatednot on this mapstarted 2015, after this paper: background citation

Vertebroplasty In The Treatment Of Acute Fracture Trial (The VITTA Trial)

TypeinterventionalSponsorCentre hospitalier de l'Université de Montréal (CHUM)Ran2015 to 2018Enrolled2ConditionsVertebral Compression FracturesArmsPercutaneous vertebroplasty, Facet block
NCT03651804 phase4withdrawnnot on this mapstarted 2019, after this paper: background citation

Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures

TypeinterventionalSponsorUniversity of California, DavisRan2019 to 2023Enrolled0ConditionsVertebral Compression Fracture, Facet Joint PainArmsRadiofrequency ablation of the medial branch nerves, Non-steroidal anti-inflammatory drugs, Bisphosphonates, Acetaminophen, Physical therapy
3 · Its place in the literature

Who cites it

477 citing papers in PubMed, 20 syntheses or guidelines pooled it, 1,415 citations in OpenAlex.

  1. Guideline
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  8. Kyphoplasty is associated with reduced mortality risk for osteoporotic vertebral compression fractures: 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 · 2024
    Pooled it
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  14. 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
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  16. 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
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  18. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
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  20. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it

417 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 4 countries.

David F KallmesDepartment of Radiology, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, USA. kallmes.david@mayo.edu
Bryan A Comstock
Patrick J Heagerty
Judith A Turner
David J Wilson
Terry H Diamond
Richard Edwards
Leigh A Gray
Lydia Stout
Sara Owen
William Hollingworth
Basavaraj Ghdoke
Deborah J Annesley-Williams
Stuart H Ralston
Jeffrey G Jarvik
Seattle University · USNuffield Orthopaedic Centre · GBGartnavel General Hospital · GBMayo Clinic · USMayo Clinic in Arizona · USNottingham University Hospitals NHS Trust · GBUniversity of Bristol · GBUniversity of Washington · USUNSW Sydney · AUWestern General Hospital · GB

Funding

SHAM-CONTROLLED TRIAL OF PERCUTANEOUS VERTEBROPLASTYR01AR049373 · NIAMS · MAYO CLINIC ROCHESTER · PI KALLMES, DAVID F · 2002 to 2008
$1.8M
Medical Research Council G0800800NIAMS NIH HHS R01 AR049373NIAMS NIH HHS R01-AR49373
6 · The paper itself

Abstract

backgroundVertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures.

methodsIn this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland-Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients' ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month.

resultsAll patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score (difference, 0.7; 95% confidence interval [CI], -1.3 to 2.8; P=0.49) or the pain rating (difference, 0.7; 95% CI, -0.3 to 1.7; P=0.19). Both groups had immediate improvement in disability and pain scores after the intervention. Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06). At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group (51% vs. 13%, P<0.001) [corrected]. There was one serious adverse event in each group.

conclusionsImprovements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group. (ClinicalTrials.gov number, NCT00068822.)

Indexed as

VertebroplastyAgedBack PainBone CementsCross-Over StudiesDisability EvaluationDouble-Blind MethodFemaleFractures, CompressionHumansInjections, SpinalMaleOsteoporosisOutcome Assessment, Health CarePain MeasurementPlacebo EffectBone Cementspolymethacrylic acidPolymethacrylic Acids

Identifiers

PMID19657122
PMCPMC2930487
OpenAlexW2059724197

What OpenQuestion holds

Textmetadata
LicenceTDM
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.