Evidence map›Paper›PMID 37648908›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 Society2024

Bone-anchored annular closure device leading to histiocytic-inflammation-induced neuropathy with resolution after removal: a case report.

Jesse J McClure, Mark E Jentoft, Sukhwinder S Sandhu, Selby G Chen, Kingsley O Abode-Iyamah

Abstract readCase Reports
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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, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 31% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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

5 authors at 2 institutions in 1 country.

Jesse J McClureDepartment of Neurosurgery, University of Virginia, 200 Jeanette Lancaster Way, Charlottesville, VA, 22901, USA. jm4wc@virginia.edu.ORCID 0000-0002-5689-4731
Mark E JentoftDepartment of Pathology, Mayo Clinic, Jacksonville, FL, USA.
Sukhwinder S SandhuDepartment of Radiology, Mayo Clinic, Jacksonville, FL, USA.
Selby G ChenDepartment of Neurosurgery, Mayo Clinic, Jacksonville, FL, USA.
Kingsley O Abode-IyamahDepartment of Neurosurgery, Mayo Clinic, Jacksonville, FL, USA.
WinnMed · USUniversity of Virginia · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo determine and report the underlying cause of local inflammation causing recurrent neuropathy and multiple operations in a patient with a Barricaid® device.

methodsAfter removal of this patient's Barricaid® device, we sent local inflammatory tissue to pathology for histochemical analysis. Upon discovery of giant cells formation with polarizable foreign bodies, we performed a literature review regarding the Barricaid® device and its elements.

resultsAfter two previous operations and three trials of conservative management, the presented patient underwent an L5/S1 TLIF with removal of her previously installed Barricaid® device. There were no signs of device instability/failure nor were there obvious signs of infection. Inflamed tissue proximal to the Barricaid® device was discovered, debrided, and sample sent to pathology. Removal of the Barricaid® device led to subsequent and durable relief of her symptoms. During review of this case, we discovered the polyethylene terephthalate (PET) weave used in the Barricaid® device is known to induce foreign body reactions, and this precise finding was seen in the majority of animal data submitted to the FDA for the device's acceptance.

conclusionGiven the constellation of this patient's symptoms, imaging, intraoperative, and pathology findings, previously published reports, and pre-approval data submitted to the FDA, we conclude that the inflammatory response to the PET weave in this patient's Barricaid® device was the ultimate cause of her continued neuropathy despite multiple prior surgical interventions.

Indexed as

Bone-Anchored ProsthesisDevice RemovalHistiocytesInflammationNervous System DiseasesForeign-Body ReactionHumansLumbar VertebraeSpinal FusionAnnular closure deviceBarricaidCase reportGiant cellInflammationPolyethylene terephthalate

Identifiers

PMID37648908
OpenAlexW4386286238

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.