Godino Oscar, Fernandez-Carballal Carlos, Català Ignasi, Moreno Ángela, Rimbau Jordi Manuel, Alvarez-Galovich Luís, Roldan Héctor
Neurosurgery Department, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
Neurosurgery Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Eur Spine J. 2025 Mar;34(3):1123-1133. doi: 10.1007/s00586-024-08595-x. Epub 2024 Dec 8.
The aim of this study was to evaluate the performance and safety of a new hernia blocking system (HBS), implanted after a limited discectomy, to prevent recurrence of lumbar disc herniation.
Prospective, multicenter (6 sites), cohort clinical investigation. Thirty patients with a postero-lateral disc herniation between L4-S1 and large annular defects (> 6 mm wide), who underwent a limited discectomy and were treated with a new HBS (DISC care, NEOS Surgery S.L.), were included. This article presents details about the investigational device, its surgical technique, intraoperative parameters, and up to 6 months follow-up outcomes. The primary endpoint of the study was to assess the incidence of early symptomatic reherniation. In addition, disc height, leg and back pain (NRS 0-10), Oswestry Disability Index (ODI), quality of life (EQ-5D-5L) and device safety, were evaluated.
gov: NCT04188236; date: 27th November 2019.
Thirty patients (43.3% female, 41.7 ± 10.9 years) were implanted with the device under evaluation in a mean of 16 ± 9.6 min. Six months after surgery, no symptomatic reherniation was detected and disc height was maintained in all patients included. All patients had a significant reduction in leg pain (> 2 points in the NRS), 92.9% improved > 15 points in the ODI and 82.6% significantly improved their quality of life (≥ 12 points in EQ VAS score). No product-related serious adverse events nor reoperations occurred.
The implantation of an HBS is a feasible and safe procedure that prevents early disc herniation recurrence in patients at high risk of reherniation.
本研究旨在评估一种新型疝封堵系统（HBS）在有限椎间盘切除术后植入，预防腰椎间盘突出症复发的性能和安全性。
前瞻性、多中心（6个地点）队列临床研究。纳入30例L4-S1节段后外侧椎间盘突出且伴有较大椎间盘环缺损（>6mm宽），接受了有限椎间盘切除术并采用新型HBS（DISC care，NEOS Surgery S.L.）治疗的患者。本文介绍了研究装置的详细信息、其手术技术、术中参数以及长达6个月的随访结果。该研究的主要终点是评估早期有症状再突出的发生率。此外，还评估了椎间盘高度、腿部和背部疼痛（数字评分量表0-10）、奥斯威斯残疾指数（ODI）、生活质量（EQ-5D-5L）以及装置安全性。
gov：NCT04188236；日期：2019年11月27日。
30例患者（43.3%为女性，年龄41.7±10.9岁）接受了评估装置的植入，平均手术时间为16±9.6分钟。术后6个月，未检测到有症状的再突出，所有纳入患者的椎间盘高度均得以维持。所有患者的腿部疼痛均显著减轻（数字评分量表>2分），92.9%的患者奥斯威斯残疾指数改善>15分，82.6%的患者生活质量显著改善（EQ视觉模拟量表评分≥12分）。未发生与产品相关的严重不良事件，也未进行再次手术。
植入HBS是一种可行且安全的手术方法，可预防再突出高风险患者的早期椎间盘突出复发。
