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

Authors:
Stefano Marcia at SS Trinità Hospital ASSL Cagliari ATS Sardegna
Stefano Marcia
  • SS Trinità Hospital ASSL Cagliari ATS Sardegna
Joshua Adam Hirsch
Joshua Adam Hirsch
Joshua Adam Hirsch
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Matteo Bellini at Azienda Ospedaliera Universitaria Senese
Matteo Bellini
Giulia Sadotti
Giulia Sadotti
Giulia Sadotti
  • This person is not on ResearchGate, or hasn't claimed this research yet.
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Abstract and Figures

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.
VAS score pre and 6-months after Lobster placement The left panel displays the boxplot of the data. Before treatment, the VAS was mostly concentrated on the upper values of the scale (median = 8; 25th percentile = 7; 75th percentile = 8). The distribution of the VAS in the post-treatment survey (median = 3; 25th percentile = 2; 75th percentile = 4); 2 outliers were identified (crosses); the one in the post-procedure was related to the patient not able to accomplish the procedure because of spine process rupture. The bar plots in the right panel show the means and SDs of the data. The mean VAS was 7.8 ± 0.7 before the procedure and it decreased to 2.9 ± 1.3 at final follow-up; the difference between pre-PDCT and post-PDCT VAS score was statistically significant (p < 0.001) by paired t-test
VAS score pre and 6-months after Lobster placement The left panel displays the boxplot of the data. Before treatment, the VAS was mostly concentrated on the upper values of the scale (median = 8; 25th percentile = 7; 75th percentile = 8). The distribution of the VAS in the post-treatment survey (median = 3; 25th percentile = 2; 75th percentile = 4); 2 outliers were identified (crosses); the one in the post-procedure was related to the patient not able to accomplish the procedure because of spine process rupture. The bar plots in the right panel show the means and SDs of the data. The mean VAS was 7.8 ± 0.7 before the procedure and it decreased to 2.9 ± 1.3 at final follow-up; the difference between pre-PDCT and post-PDCT VAS score was statistically significant (p < 0.001) by paired t-test
… 
ZCQ score pre and 6-months after Lobster placement The left panel displays the boxplot of the data. Before treatment the median ZCQ scores was 58 (25th percentile = 45; 75th percentile = 66); no outliers were identified. After the treatment, the median ZCQ score was 27 (25th percentile = 24; 75th percentile = 33); 5 outliers were identified. The bar plots in the right panel show the means and SDs of the data. The decrease of the mean of the ZCQ from 56.4 ± 10.9 to 28.6 ± 6.4 was significant (p < 0.001) by paired t-test
ZCQ score pre and 6-months after Lobster placement The left panel displays the boxplot of the data. Before treatment the median ZCQ scores was 58 (25th percentile = 45; 75th percentile = 66); no outliers were identified. After the treatment, the median ZCQ score was 27 (25th percentile = 24; 75th percentile = 33); 5 outliers were identified. The bar plots in the right panel show the means and SDs of the data. The decrease of the mean of the ZCQ from 56.4 ± 10.9 to 28.6 ± 6.4 was significant (p < 0.001) by paired t-test
… 
Lobster® device characteristic. A Lobster device is mounted on a dedicated tube for its placement and deployment. B Lobster device in close fashion. C Lobster device with opened wings. D–F Lobster placement: the correct placement of the device is monitored under fluoroscopy (E, F); once the correct position is achieved, the device can be opened and released
Lobster® device characteristic. A Lobster device is mounted on a dedicated tube for its placement and deployment. B Lobster device in close fashion. C Lobster device with opened wings. D–F Lobster placement: the correct placement of the device is monitored under fluoroscopy (E, F); once the correct position is achieved, the device can be opened and released
… 
)PID procedure. A Lobster placement is accomplished under fluoroscopic guidance through a 1-cm skin incision utilizing a unilateral approach as stand-alone decompressive procedure preserving the thoracolumbar fascia thus SSL. Tube 1 is inserted in order to obtain interspinous ligament perforation. B–D Increasing in caliper dilatators is subsequently inserted in order to advance the tines of the tube dilator 3 in between the spinous processes. E, F Tube dilators 1 and 2 are removed in order to define the adequate implant size using different caliber probes; once the correct size is found, the Lobster is inserted mounted on the tip of the implant holder shaft (see Fig. 1 and 3)
)PID procedure. A Lobster placement is accomplished under fluoroscopic guidance through a 1-cm skin incision utilizing a unilateral approach as stand-alone decompressive procedure preserving the thoracolumbar fascia thus SSL. Tube 1 is inserted in order to obtain interspinous ligament perforation. B–D Increasing in caliper dilatators is subsequently inserted in order to advance the tines of the tube dilator 3 in between the spinous processes. E, F Tube dilators 1 and 2 are removed in order to define the adequate implant size using different caliber probes; once the correct size is found, the Lobster is inserted mounted on the tip of the implant holder shaft (see Fig. 1 and 3)
… 
PID displacement. A Antero-posterior fluoroscopy demonstrated partial opening of PID wings. B The subsequent CT scan shows a misplacement subsequent to facet joint conflict. C The MRI performed as result of patient’s worsening clinical conditions demonstrated PID displaced within the paravertebral muscles. D The PID removal was carried out under fluoroscopic guidance using the same deployment tool. E–G Two PID were implanted after the removal in relation to preexisting dual level spinal stenosis
+1
PID displacement. A Antero-posterior fluoroscopy demonstrated partial opening of PID wings. B The subsequent CT scan shows a misplacement subsequent to facet joint conflict. C The MRI performed as result of patient’s worsening clinical conditions demonstrated PID displaced within the paravertebral muscles. D The PID removal was carried out under fluoroscopic guidance using the same deployment tool. E–G Two PID were implanted after the removal in relation to preexisting dual level spinal stenosis
… 
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Vol.:(0123456789)
Neuroradiology (2024) 66:1049–1056
https://doi.org/10.1007/s00234-024-03343-w
SPINAL NEURORADIOLOGY
Feasibility, safety, andefficacy ofanew percutaneous interspinous
device: aretrospective multicenter study
StefanoMarcia1· JoshuaAdamHirsch2· MatteoBellini3· GiuliaSadotti4· LuigiManfré5· AldoErosDeVivo5·
EmanuelePiras1· GiacomoZini6· ChiaraZini7
Received: 8 January 2024 / Accepted: 19 March 2024 / Published online: 3 April 2024
© The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024, corrected publication 2024
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. Techni-
cal 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.
Keywords Spinal stenosis· Percutaneous interspinous device· Neurogenic intermittent claudication
* Chiara Zini
zini.chiara@gmail.com
Stefano Marcia
stemarcia@gmail.com
Joshua Adam Hirsch
JA-HIRSCH@mgh.harvard.edu
Matteo Bellini
matteo.bellini@me.com
Giulia Sadotti
sadotti.giulia@gmail.com
Luigi Manfré
lmanfre@icloud.com
Aldo Eros De Vivo
devivoeros@gmail.com
Emanuele Piras
emanuelexpiras@gmail.com
Giacomo Zini
ing.giacomozini@gmail.com
1 UOC Radiologia SS, Trinità Hospital, 09121Cagliari, Italy
2 Department ofRadiology, Massachusetts General Hospital,
Harvard Medical School, Boston, MA, USA
3 UOC Neuroimmagini, Neuroradiologia Clinica E Funzionale
Dipartimento Di Scienze Neurologiche E Motorie Azienda
Ospedaliera Universitaria Senese, Siena, Italy
4 UOC Radiodiagnostica, Ospedali Riuniti Della Val Di
Chiana, Montepulciano, Siena, Italy
5 Minimal Invasive Spine Dept ofNeurosurgery, Istituto
Oncologico del Mediterraneo IOM, Viagrande, Italy
6 Ingegneria Civile E Ambientale (DICEA), Università Di
Firenze, Florence, Italy
7 Department ofRadiology, USL Toscana Centro, Florence,
Italy
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
... Minimal invasive surgery has become widely accepted in all types of disciplines, ranging from visceral to orthopedic surgery [1][2][3]. New instruments permit percutaneous surgery for the spine and pelvis [29][30][31][32][33]. Nevertheless, to our knowledge, an attempt to generalize an algorithm with guidelines for MIO approaches has not been established yet. ...
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Purpose Interspinous process devices (IPDs) are implanted to treat patients with intermittent neurogenic claudication (INC) based on lumbar spinal stenosis. It is hypothesized that patients with lumbar spinal stenosis treated with IPD have a faster short-term recovery, an equal outcome after 2 years and less back pain compared with bony decompression. Methods A randomized design with variable block sizes was used, with allocations stratified according to center. Allocations were stored in prepared opaque, coded and sealed envelopes, and patients and research nurses were blind throughout the follow-up. Five neurosurgical centers (including one academic and four secondary level care centers) included participants. 211 participants were referred to the Leiden–The Hague Spine Prognostic Study Group. 159 participants with INC based on lumbar spinal stenosis at one or two levels with an indication for surgery were randomized into two groups. Patients and research nurses were blinded for the allocated treatment throughout the study period. 80 participants received an IPD and 79 participants underwent spinal bony decompression. The primary outcome at long-term (2-year) follow-up was the score for the Zurich Claudication Questionnaire. Repeated measurement analyses were applied to compare outcomes over time. Results At two years, the success rate according to the Zurich Claudication Questionnaire for the IPD group [69 % (95 % CI 57–78 %)] did not show a significant difference compared with standard bony decompression [60 % (95 % CI 48–71 %) p value 0.2]. Reoperations, because of absence of recovery, were indicated and performed in 23 cases (33 %) of the IPD group versus 6 (8 %) patients of the bony decompression group (p
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Objective: The aim of this study is to explain the technique used for removing and replacing a novel percutaneous interspinous device (PID). Procedure: Three male patients, with a mean age of 66 years (range 62–72), were included in the study due to displacement ( N = 2) or misplacement ( N = 1) of the novel PID. This occurred after a mean of 23.3 ± 10.5 days from the initial placement (range 13–34) at the L4–L5 level ( N = 1) and L3–L4 level ( N = 2). Following the removal of the PID, four new devices were implanted. Conclusion: The novel PID can be safely removed either immediately after its placement during the procedure or after a certain period of days or months from its implantation. The removal procedure can be performed percutaneously under imaging guidance, by closing the four retractable wings, using the same instrumentation as utilized during the initial implantation.
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Successful use of percutaneous interspinous spacers and adjunctive spinoplasty in a 9 year cohort of patients
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Purpose Lumbar spinal canal stenosis and lumbar spinal foraminal stenosis are common, degenerative pathologies which can result in neurogenic claudication and have a negative impact on function and quality of life. Percutaneous interspinous devices (PIDs) are a recently-developed, minimally-invasive, alternative treatment option. This study details a 9 year single-centre experience with PIDs and examines the complementary use of spinous process augmentation (spinoplasty) to reduce failure rates. Methods A retrospective cohort assessment of 800 consecutive patients who presented to a specialized spine hospital was performed with 688 receiving treatment. Inclusion was based on high-grade stenosis, failure of conservative management and electromyography. 256 had a PID alone while 432 had concurrent polymethyl methacrylate (PMMA) augmentation of the adjacent spinous processes. The patients were followed up at 3 and 12 months using the Zurich Claudication Questionnaire (ZCQ) and Oswestry Disability Index (ODI). Results Both groups showed marked improvement in the patients’ ZCQ scores (3.2 to 1.3) and ODI scores (32 to 21), with strong satisfaction results (1.7). The symptom recurrence rate from complications for the group which received concurrent spinous process augmentation was reduced when compared with the PID alone cohort (<1% vs 11.3%). Conclusion This study demonstrates the efficacy of percutaneous interspinous devices in treating lumbar spinal stenosis. It also provides evidence that concurrent spinous process augmentation reduces the rate of symptom recurrence.
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Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System
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Interventional radiology provides a wide variety of vascular, nonvascular, musculoskeletal, and oncologic minimally invasive techniques aimed at therapy or palliation of a broad spectrum of pathologic conditions. Outcome data for these techniques are globally evaluated by hospitals, insurance companies, and government agencies targeting in a high-quality health care policy, including reimbursement strategies. To analyze effectively the outcome of a technique, accurate reporting of complications is necessary. Throughout the literature, numerous classification systems for complications grading and classification have been reported. Until now, there has been no method for uniform reporting of complications both in terms of definition and grading. The purpose of this CIRSE guideline is to provide a classification system of complications based on combining outcome and severity of sequelae. The ultimate challenge will be the adoption of this system by practitioners in different countries and health economies within the European Union and beyond.
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Biomechanical study of dynamic changes in L4–L5 foramen surface area in flexion and extension after implantation of four interspinous process devices
Article
  • Feb 2015
Background Lumbar spinal stenosis is a major public health issue. Interspinous devices implanted using minimally invasive techniques may constitute an alternative to the reference standard of bony decompression with or without intervertebral fusion. However, their indications remain unclear, due to a paucity of clinical and biomechanical data. Our objective was to evaluate the effects of four interspinous process devices implanted at L4–L5 on the intervertebral foramen surface areas at the treated and adjacent levels, in flexion and in extension. Materials and method Six fresh frozen human cadaver lumbar spines (L2–sacrum) were tested on a dedicated spinal loading frame, in flexion and extension, from 0 to 10 N·m, after preparation and marking of the L3–L4, L4–L5, and L5–S1 foramina. Stereoscopic 3D images were acquired at baseline then after implantation at L4–L5 of each of the four devices (Inspace®, Synthes; X-Stop®, Medtronic; Wallis®, Zimmer; and Diam®, Medtronic). The surface areas of the three foramina of interest were computed. Results All four devices significantly opened the L4–L5 foramen in extension. The effects in flexion separated the devices into two categories. With the two devices characterized by fixation in the spinous processes (Wallis® and Diam®), the L4–L5 foramen opened only in extension; whereas with the other two devices (X-Stop® and Inspace®), the L4–L5 foramen opened not only in extension, but also in flexion and in the neutral position. None of the devices implanted at L4–L5 modified the size of the L3–L4 foramen. X-Stop® and Diam® closed the L5–S1 foramen in extension, whereas the other two devices had no effect at this level. Conclusion Our results demonstrate that interspinous process devices modify the surface area of the interspinous foramina in vitro. Clinical studies are needed to clarify patient selection criteria for interspinous process device implantation. Level of evidence Level IV. Investigating an orthopaedic device.
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