Evidence map›Paper›PMID 35976438›Full record

ArticleEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2022

Venous injection of a triphasic calcium-based implant in a sheep model of pulmonary embolism demonstrates minimal acute systemic effects.

Caroline Constant, John D Stroncek, Stephan Zeiter, Daniel Arens, Dirk Nehrbass, Dominic Gehweiler, Ursula Menzel, Lorin M Benneker, Ronald S Hill, Christoph E Albers

Open access · hybridAbstract read
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In one paragraph

Article in 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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

10 authors at 5 institutions in 3 countries.

Caroline ConstantAO Research Institute Davos, Davos, Switzerland.ORCID 0000-0002-7846-5612
John D StroncekAgNovos Healthcare, 7301 Calhoun Place Suite 100, Rockville, MD, 20855, USA. jstroncek@agnovos.com.ORCID 0000-0002-8599-5750
Stephan ZeiterAO Research Institute Davos, Davos, Switzerland.ORCID 0000-0002-8155-4202
Daniel ArensAO Research Institute Davos, Davos, Switzerland.ORCID 0000-0002-2705-0812
Dirk NehrbassAO Research Institute Davos, Davos, Switzerland.ORCID 0000-0002-4871-5473
Dominic GehweilerAO Research Institute Davos, Davos, Switzerland.ORCID 0000-0001-7148-9569
Ursula MenzelAO Research Institute Davos, Davos, Switzerland.
Lorin M BennekerSpine Surgery, Sonnenhofspital, University of Bern, Bern, Switzerland.
Ronald S HillAgNovos Healthcare, 7301 Calhoun Place Suite 100, Rockville, MD, 20855, USA.ORCID 0000-0001-8789-2475
Christoph E AlbersInselspital, University Hospital Bern, Bern, Switzerland.ORCID 0000-0003-2751-3458
AO Foundation · CHAgency for Healthcare Research and Quality · USLenovo (China) · CNUniversity Hospital of Bern · CHUniversity of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeImplant leakage is the most common complication of vertebral augmentation. Alternative injectable materials must demonstrate intravascular safety comparable to or better than polymethyl methacrylate (PMMA). This study assessed the systemic effects of a triphasic calcium-based implant or PMMA injected directly into the femoral vein in a large animal model designed to mimic severe intravascular implant leakage.

methodsSix skeletally mature female sheep were randomly assigned (n = 3) to either the PMMA or the triphasic implant (AGN1, composition: calcium sulfate, β-tricalcium phosphate, brushite) treatment group. Femoral veins of each sheep were directly injected with 0.5 mL of implant material to mimic leakage volumes reported during PMMA vertebroplasty. To compare acute systemic effects of the materials, cardiovascular parameters, laboratory coagulation markers, and calcium and sulfate serum levels were monitored for 60 min after implant injection. Thrombotic and embolic events were evaluated by radiologic imaging, necropsy, and histopathology.

resultsHeart rate, systemic arterial blood pressure, arterial oxygenation, arterial carbon dioxide content, and coagulation markers remained within physiological range after either AGN1 or PMMA injection. No blood flow interruption in the larger pulmonary vessels was observed in either group. Lung histopathology revealed that the severity of thrombotic changes after AGN1 injection was minimal to slight, while changes after PMMA injection were minimal to massive.

conclusionAcute systemic effects of intravascular AGN1 appeared to be comparable to or less than that of intravascular PMMA. Furthermore, in this preliminary study, the severity and incidence of pulmonary histological changes were lower for AGN1 compared to PMMA.

Indexed as

Pulmonary EmbolismVertebroplastyAnimalsBone CementsCalciumCalcium SulfateCarbon DioxideFemalePolymethyl MethacrylateSheepBone CementsCalciumCalcium SulfateCarbon DioxidePolymethyl MethacrylateKyphoplastyPMMAPulmonary embolismTriphasic calcium implantVertebral augmentationVertebroplasty

Identifiers

PMID35976438
OpenAlexW4292079471

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.