Evidence map›Paper›PMID 33099702›Full record

ArticleCardiovascular and interventional radiology2021

Efficacy of a Novel Vertebral Body Augmentation System in the Treatment of Patients with Symptomatic Vertebral Body Fractures.

Stefano Marcia, Emanuele Piras, Joshua A Hirsch, Alessio Mereu, Mariangela Marras, Alessio Spinelli, Luca Saba

Open access · hybridAbstract read
In one paragraph

Article in Cardiovascular and interventional radiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
  3. Treatment of thoracolumbar burst fractures: SpineJackJournal of spine surgery (Hong Kong) · 2022
    Article
  4. Article
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

7 authors at 4 institutions in 2 countries.

Stefano MarciaUOC of Radiology, Ospedale SS Trinità, ATS, Cagliari, Italy.
Emanuele PirasUOC of Radiology, Ospedale SS Trinità, ATS, Cagliari, Italy.
Joshua A HirschNeuroendovascular Program, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Alessio MereuDepartment of Radiology, Azienda Ospedaliero Universitaria (A.O.U.), Di Cagliari, Polo di Monserrato s.s. 554 Monserrato, 09045, Cagliari, Italy.
Mariangela MarrasUOC of Radiology, Ospedale Brotzu, AOB, Cagliari, Italy.
Alessio SpinelliUOC of Radiology, Ospedale SS Trinità, ATS, Cagliari, Italy.
Luca SabaDepartment of Radiology, Azienda Ospedaliero Universitaria (A.O.U.), Di Cagliari, Polo di Monserrato s.s. 554 Monserrato, 09045, Cagliari, Italy. lucasaba@tiscali.it.ORCID http://orcid.org/0000-0003-2870-3771
Santissima Trinità · ITAzienda Ospedaliero-Universitaria Cagliari · ITAzienda Ospedaliera G. Brotzu · ITHarvard University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and efficacy of a novel augmentation implant in the treatment of patients with symptomatic vertebral body fractures. MATERIALS AND

methodsThirty consecutive patients (seven males and 23 females), mean age of 70 years (range 56 to 89) with osteoporotic fractures and/or low-energy trauma fractures (osteoporosis confirmed by CT), were enrolled in an IRB-approved prospective study. The type of fracture was classified according to the Magerl classification. The patients were treated with the Tektona

resultsA total of 37 vertebral bodies, mostly from T6 to L5, were treated in the 30 enrolled patients. In 67.6% of the cases (n = 25), lumbar fractures were treated. Most of the fractures (43%; n = 16) were A1.1 according to the Magerl classification. A significant pain reduction evaluated by VAS scores (p < 0.0001) was observed on average 7.6 (before the procedure) to 2.8 (immediately post-treatment), 2.1 and 2.7 (after 6 and 12 months later, respectively). The mean ODI score was 55.5% before treatment, and this was statistically significant reduced to 22.3% and 26.9%, respectively, at 6 and 12 months after treatment (p < 0.0001). The SF36 scores, both physical and mental components, showed statistically significant variations (p < 0.0001) whose direction was subpopulation dependent.

conclusionPatients with confirmed osteoporosis, suffering from symptomatic vertebral body fractures (osteoporotic and/or low-energy traumatic), were treated safely and effectively using this novel implant.

Indexed as

AgedAged, 80 and overFemaleFracture Fixation, InternalHumansLongitudinal StudiesMagnetic Resonance ImagingMaleMiddle AgedOsteoporotic FracturesProspective StudiesProstheses and ImplantsQuality of LifeSpinal FracturesTomography, X-Ray ComputedTreatment OutcomeOsteoporosisVertebral body augmentationVertebral body fractures

Identifiers

PMID33099702
PMCPMC7806563
OpenAlexW3093683156

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Registered trials

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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.