Evidence map›Paper›PMID 38568239›Full record

ArticleNeuroradiology2024

Feasibility, safety, and efficacy of a new percutaneous interspinous device: a retrospective multicenter study.

Stefano Marcia, Joshua Adam Hirsch, Matteo Bellini, Giulia Sadotti, Luigi Manfré, Aldo Eros De Vivo, Emanuele Piras, Giacomo Zini, Chiara Zini

Erratum issuedAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Neuroradiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 26% 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, 2 citations in OpenAlex.

  1. Advancing fracture management: the role of minimally invasive osteosynthesis in orthopedic trauma care.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2024
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 2 countries.

Stefano MarciaUOC Radiologia SS, Trinità Hospital, 09121, Cagliari, Italy.
Joshua Adam HirschDepartment of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Matteo BelliniUOC Neuroimmagini, Neuroradiologia Clinica E Funzionale Dipartimento Di Scienze Neurologiche E Motorie Azienda Ospedaliera Universitaria Senese, Siena, Italy.
Giulia SadottiUOC Radiodiagnostica, Ospedali Riuniti Della Val Di Chiana, Montepulciano, Siena, Italy.
Luigi ManfréMinimal Invasive Spine Dept of Neurosurgery, Istituto Oncologico del Mediterraneo IOM, Viagrande, Italy.
Aldo Eros De VivoMinimal Invasive Spine Dept of Neurosurgery, Istituto Oncologico del Mediterraneo IOM, Viagrande, Italy.
Emanuele PirasUOC Radiologia SS, Trinità Hospital, 09121, Cagliari, Italy.
Giacomo ZiniIngegneria Civile E Ambientale (DICEA), Università Di Firenze, Florence, Italy.
Chiara ZiniDepartment of Radiology, USL Toscana Centro, Florence, Italy. zini.chiara@gmail.com.ORCID http://orcid.org/0000-0003-3456-4106
Istituto Neurologico Mediterraneo · ITSantissima Trinità · ITAzienda Ospedaliera Universitaria Senese · ITAzienda Usl Toscana Centro · ITHarvard University · USUniversity of Florence · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate safety and efficacy of the novel percutaneous interspinous device (PID) for the treatment of symptomatic degenerative lumbar spinal stenosis (DLSS) in 3 different centers.

methodsFrom November 2016 to March 2020, 255 patients (male 125, mean age 71.2 years old range 49-91 years old) with neurogenic claudication, confirmed by electromyography, related to mono or bi-segmental lumbar central canal and/or foraminal stenosis were enrolled in the study. Magnetic resonance (MR) and/or computer tomography (CT), physical exam, and Visual Analogue Scale (VAS) and Zurich Claudication Questionnaire (ZCQ) were performed before and 6 months after the procedure. All treatments were performed under fluoroscopic guidance with local anesthesia and mild sedation. Technical success was defined as correct placement of the Lobster® (Demetrios Medical, Firenze, Italy) PID as demonstrated by computer tomography (CT) performed immediately after treatment; spinoplasty was performed in selected patients.

resultsPID placement was accomplished with a 99.6% success rate (257/258). The one device that was not implanted was due to a spinous process fracture. In 28 patients, more than 1 device was implanted in the same session (max 3 PIDs); 6 patients required a second implant in different session. A total of 172 prophylactic spinoplasties were performed (59.3%). No major complications occurred; 3 device misplacements were successfully treated with percutaneous retrieval and new device deployment. 99.6% of patients experienced clinical improvement.

conclusionLobster PID is an effective and safe minimally invasive decompression method for central canal and neural foraminal stenosis when patients are correctly selected.

Indexed as

Feasibility StudiesSpinal StenosisAgedAged, 80 and overDecompression, SurgicalFemaleHumansLumbar VertebraeMaleMiddle AgedProstheses and ImplantsRetrospective StudiesTomography, X-Ray ComputedTreatment OutcomeNeurogenic intermittent claudicationPercutaneous interspinous deviceSpinal stenosis

Identifiers

PMID38568239
OpenAlexW4393854258

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.