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

  • Spinal Neuroradiology
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A Correction to this article was published on 24 April 2024

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Abstract

Purpose

To 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.

Methods

From 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.

Results

PID 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.

Conclusion

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

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Funding

No funding was received to assist with the preparation of this manuscript.

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Authors and Affiliations

  1. UOC Radiologia SS, Trinità Hospital, 09121, Cagliari, Italy

    Stefano Marcia & Emanuele Piras

  2. Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

    Joshua Adam Hirsch

  3. UOC Neuroimmagini, Neuroradiologia Clinica E Funzionale Dipartimento Di Scienze Neurologiche E Motorie Azienda Ospedaliera Universitaria Senese, Siena, Italy

    Matteo Bellini

  4. UOC Radiodiagnostica, Ospedali Riuniti Della Val Di Chiana, Montepulciano, Siena, Italy

    Giulia Sadotti

  5. Minimal Invasive Spine Dept of Neurosurgery, Istituto Oncologico del Mediterraneo IOM, Viagrande, Italy

    Luigi Manfré & Aldo Eros De Vivo

  6. Ingegneria Civile E Ambientale (DICEA), Università Di Firenze, Florence, Italy

    Giacomo Zini

  7. Department of Radiology, USL Toscana Centro, Florence, Italy

    Chiara Zini

Authors
  1. Stefano Marcia
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  2. Joshua Adam Hirsch
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  3. Matteo Bellini
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  4. Giulia Sadotti
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  5. Luigi Manfré
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  6. Aldo Eros De Vivo
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  7. Emanuele Piras
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  8. Giacomo Zini
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  9. Chiara Zini
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Corresponding author

Correspondence to Chiara Zini.

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Conflict of interest

The authors have no competing interests to declare that are relevant to the content of this article.

Ethical approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of ATS Sardegna (Date 5/05/2020 / No. 231/2020).

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Informed consent was obtained from all individual participants included in the study.

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The original online version of this article was revised: The original article contains a spelling error in author name. The author “Josh Adam Hirsh” should be corrected to “Joshua Adam Hirsch”.

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Marcia, S., Hirsch, J.A., Bellini, M. et al. Feasibility, safety, and efficacy of a new percutaneous interspinous device: a retrospective multicenter study. Neuroradiology (2024). https://doi.org/10.1007/s00234-024-03343-w

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