Evidence map›Paper›PMID 29743284›Full record

Trial reportBMJ (Clinical research ed.)2018

Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial.

Cristina E Firanescu, Jolanda de Vries, Paul Lodder, Alexander Venmans, Marinus C Schoemaker, Albert J Smeets, Esther Donga, Job R Juttmann, Caroline A H Klazen, Otto E H Elgersma and 7 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2018. 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 NCT01200277 (A Randomised Sham Controlled Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures), which is not on this map. Cited by 107 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 12 pooled it
28.2field-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.

NCT01200277 phase3completednot on this map

A Randomised Sham Controlled Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures

TypeinterventionalSponsorElisabeth-TweeSteden ZiekenhuisRan2011 to 2014Enrolled80ConditionsOsteoporosis, Vertebral FractureArmspercutaneous vertebroplasty, sham procedure
3 · Its place in the literature

Who cites it

107 citing papers in PubMed, 12 syntheses or guidelines pooled it, 220 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
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  5. Pooled it
  6. Early cement augmentation may be a good treatment option for pain relief for osteoporotic 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 · 2023
    Pooled it
  7. 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
    Pooled it
  8. Pooled it
  9. 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
  10. 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
  11. European guidance for the diagnosis and management of osteoporosis in postmenopausal women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Guideline
  12. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.The Cochrane database of systematic reviews · 2018
    Pooled it
  13. Predictors for quality of life improvement after acute osteoporotic vertebral fracture: results of post hoc analysis of a prospective randomized study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021
    Trial
  14. Article
  15. Bracing versus balloon kyphoplasty for acute osteoporotic vertebral fractures with poor prognostic radiological factors: a propensity score-matched comparison.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Article
  16. Review
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  18. Article
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47 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 7 institutions in 2 countries.

Cristina E FiranescuDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands crisfiranescu@hotmail.com.
Jolanda de VriesDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands.
Paul LodderDepartment of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.
Alexander VenmansDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands.
Marinus C SchoemakerDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands.
Albert J Smeets
Esther DongaDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands.
Job R JuttmannDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands.
Caroline A H KlazenDepartment of Radiology, Medisch Spectrum Twente, Enschede, Netherlands.
Otto E H ElgersmaDepartment of Radiology, Albert Schweitzer Hospital, Dordrecht, Netherlands.
Frits H JansenDepartment of Radiology, Catharina Hospital, Eindhoven, Netherlands.
Alexander V TielbeekDepartment of Radiology, Catharina Hospital, Eindhoven, Netherlands.
Issam BoukrabDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands.
Karen SchonenbergDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands.
Willem Jan J van RooijDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands.
Joshua A HirschDepartment of Radiology, Massachusetts General Hospital, MA, Boston, USA.
Paul N M LohleDepartments of Radiology and Internal Medicine, Elisabeth TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, Netherlands.
Elisabeth-TweeSteden Ziekenhuis · NLAlbert Schweitzer Ziekenhuis · NLCatharina Ziekenhuis · NLMassachusetts General Hospital · USMedisch Spectrum Twente · NLRadboud University Nijmegen · NLTilburg University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body.

designRandomised, double blind, sham controlled clinical trial.

settingFour community hospitals in the Netherlands, 2011-15.

participants180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89).

interventionsParticipants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group.

main outcome measuresMain outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months' follow-up.

resultsThe mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval -0.53 to 0.94) at baseline, -0.43 (-1.17 to 0.31) at one day, -0.11 (-0.85 to 0.63) at one week, 0.41 (-0.33 to 1.15) at one month, 0.21 (-0.54 to 0.96) at three months, 0.39 (-0.37 to 1.15) at six months, and 0.45 (-0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months' follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction.

conclusionsPercutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months' follow-up among patients with acute osteoporotic vertebral compression fractures.

trial registrationClinicalTrials.gov NCT01200277.

Indexed as

VertebroplastyAgedAged, 80 and overBack PainBone CementsDisability EvaluationDouble-Blind MethodFemaleFractures, CompressionHumansMaleOsteoporotic FracturesOutcome Assessment, Health CarePain MeasurementPostoperative ComplicationsSpinal FracturesBone Cements

Identifiers

PMID29743284
PMCPMC5941218
OpenAlexW2802265732

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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.