Department of Diagnostic and Interventional Radiology, Nice University Hospital, Hôpital Pasteur 2, Nice, France.
South West London, Elective Orthopaedic Centre (SWLEOC), Epsom, KT18 7EG, London, UK.
Neuroradiology. 2022 Sep;64(9):1887-1895. doi: 10.1007/s00234-022-02977-y. Epub 2022 May 31.
To evaluate clinical and radiological outcomes of a series of patients treated with a removable percutaneous interspinous process spacer (IPS) (LobsterProject® Techlamed®) for symptomatic degenerative lumbar spinal stenosis (DLSS).
All patients treated in two centres with this IPS during 2019 were retrospectively reviewed. Procedures were performed under deep sedation or general anaesthesia by two interventional radiologists. Patients were clinically evaluated before intervention and at 3-month follow-up with Visual Analog Scales for pain (VAS), Oswestry Disability Index (ODI) and radiologically with MRI or CT scans. Neural foramina were independently measured for each patient on pre- and post-procedural CT scans by two radiologists.
Fifty-nine patients were treated in the selected period of which fifty-eight had complete documentation (mean age 71.2 ± 9.2 years [55-92], 32 males, 26 females). Forty-eight interventions were performed under deep sedation and ten under general anaesthesia, without procedural complications. Clinical follow-up at 3 months showed a significant reduction of pain (VAS from 83 ± 9 to 29 ± 19, - 65%; p < 0.001) and an improvement in functional outcomes (ODI from 31 ± 12 to 13 ± 10%, - 58%; p < 0.001). There was one case of unsatisfactory positioning post procedure, two cases of posterior migration at 3-month follow-up and one case of spinous process fracture. Mean neural foramina area increased from 77 ± 23 to 95 ± 27 mm (+ 26%; p < 0.001) with very good inter-observer reliability (Cronbach's alpha = 0.899).
Percutaneous minimally invasive insertion of a removable IPS device demonstrates a favourable safety profile, good clinical outcomes at 3 months, and apparent anatomical increase in foraminal dimensions.
ClinicalTrials.gov Identifier: NCT05203666-Release Date: 21 January 2022, retrospectively registered.
评估一系列使用可移除经皮棘突间撑开器（LobsterProject®Techlamed®）治疗症状性退行性腰椎管狭窄症（DLSS）患者的临床和影像学结果。
回顾性分析 2019 年在两个中心使用该 IPS 治疗的所有患者。由两位介入放射科医生在深度镇静或全身麻醉下进行手术。在干预前和 3 个月随访时，通过视觉模拟量表（VAS）、Oswestry 残疾指数（ODI）对患者进行临床评估，并通过 MRI 或 CT 扫描进行影像学评估。两位放射科医生分别对每位患者的术前和术后 CT 扫描进行神经孔独立测量。
在选定期间，59 名患者接受了治疗，其中 58 名患者的资料完整（平均年龄 71.2±9.2 岁[55-92]，男性 32 名，女性 26 名）。48 例手术在深度镇静下进行，10 例在全身麻醉下进行，无手术并发症。3 个月的临床随访显示疼痛明显减轻（VAS 从 83±9 降至 29±19，-65%；p<0.001），功能结果改善（ODI 从 31±12 降至 13±10%，-58%；p<0.001）。术后有 1 例定位不满意，3 个月时后有 2 例后移，1 例棘突骨折。神经孔面积平均从 77±23 增加到 95±27mm（+26%；p<0.001），观察者间可靠性非常好（Cronbach's alpha=0.899）。
经皮微创植入可移除 IPS 装置具有良好的安全性，3 个月时临床疗效良好，椎间孔尺寸明显增加。
ClinicalTrials.gov 标识符：NCT05203666-发布日期：2022 年 1 月 21 日，回顾性注册。
