UOC Radiologia SS, Trinità Hospital, 09121, Cagliari, Italy.
Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Neuroradiology. 2024 Jun;66(6):1049-1056. doi: 10.1007/s00234-024-03343-w. Epub 2024 Apr 3.
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.
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.
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.
Lobster PID is an effective and safe minimally invasive decompression method for central canal and neural foraminal stenosis when patients are correctly selected.
在 3 家不同中心评估新型经皮棘突间装置（PID）治疗症状性退行性腰椎管狭窄症（DLSS）的安全性和有效性。
2016 年 11 月至 2020 年 3 月，255 名（男 125 名，平均年龄 71.2 岁，年龄 49-91 岁）患者因单节段或双节段腰椎中央管和/或神经孔狭窄导致神经源性跛行，经肌电图证实，进行了这项研究。所有患者在术前和术后 6 个月进行磁共振成像（MR）和/或计算机断层扫描（CT）、体格检查以及视觉模拟量表（VAS）和苏黎世跛行问卷（ZCQ）。所有治疗均在局部麻醉和轻度镇静下在透视引导下进行。将 Lobster®（意大利佛罗伦萨的 Demetrios Medical）PID 正确放置定义为治疗后立即进行 CT 检查时的技术成功；在选择的患者中进行了 spinoplasty。
PID 放置成功率为 99.6%（257/258）。有 1 个装置未植入，原因是棘突骨折。在 28 名患者中，在同一时段植入了 1 个以上的装置（最多 3 个 PID）；6 名患者需要在不同时段进行第二次植入。共进行了 172 例预防性 spinoplasty（59.3%）。无重大并发症发生；3 例装置错位经皮取出和新装置植入成功治疗。99.6%的患者临床症状改善。
在正确选择患者的情况下，Lobster PID 是一种有效且安全的微创中央管和神经孔狭窄减压方法。
