Soto Eliezer, Esposito Michael F
Interventional Spine and Pain Institute, Vero Beach, Florida, USA.
University of Central Florida, College of Medicine, Orlando, Florida, USA.
J Pain Res. 2025 Aug 27;18:4431-4441. doi: 10.2147/JPR.S522987. eCollection 2025.
Lumbar spinal stenosis (LSS) is a common degenerative spinal condition that limits function due to reduced space for neurovascular structures. Traditional direct open lumbar decompression (DOLD) is the standard treatment after conservative measures fail. Recently, minimally invasive options such as percutaneous image-guided lumbar decompression (PILD), interspinous spacers (ISS), and interspinous fixation devices (ISFD) have gained popularity for moderate LSS without spinal instability.
This retrospective study evaluated the safety and efficacy of ISFD in patients with LSS treated at our center.
Data from 45 patients (26 males, 19 females) treated with ISFD between January 2023 and October 2024 were analyzed. Adverse events and pain outcomes were recorded using numerical rating scale (NRS) scores at baseline, 2 weeks, 1 month, and 3 months post-procedure.
Only one minor complication was reported on the procedure day. procedure day. Mean NRS pain scores improved from 7.5 (baseline) to 3.5 (2 weeks), 3.0 (1 month), and 3.5 (3 months) (P < 0.001). At 2 weeks, 50% of patients had pain reductions ≥51%; at 1 month, 57.4% experienced ≥51% reduction; and by 3 months, 73% had more than 50% pain reduction (P < 0.001), indicating significant pain improvement over time.
This was a single-center retrospective study with a small sample size and relatively short follow-up time.
ISFD appears to be a safe and effective minimally invasive treatment for LSS. Larger randomized controlled trials are needed to compare devices and refine procedural techniques.
腰椎管狭窄症（LSS）是一种常见的脊柱退行性疾病，由于神经血管结构的空间减小而限制功能。传统的直接开放腰椎减压术（DOLD）是保守治疗失败后的标准治疗方法。最近，诸如经皮影像引导腰椎减压术（PILD）、棘突间撑开器（ISS）和棘突间固定装置（ISFD）等微创选择在治疗无脊柱不稳的中度LSS患者中受到欢迎。
本回顾性研究评估了ISFD在本中心治疗的LSS患者中的安全性和有效性。
分析了2023年1月至2024年10月期间接受ISFD治疗的45例患者（26例男性，19例女性）的数据。使用数字评分量表（NRS）在术前基线、术后2周、1个月和3个月记录不良事件和疼痛结果。
手术当天仅报告了1例轻微并发症。平均NRS疼痛评分从7.5（基线）改善至3.5（2周）、3.0（1个月）和3.5（3个月）（P<0.001）。在2周时，50%的患者疼痛减轻≥51%；在1个月时，57.4%的患者疼痛减轻≥51%；到3个月时，73%的患者疼痛减轻超过50%（P<0.001），表明随着时间推移疼痛有显著改善。
这是一项单中心回顾性研究，样本量小且随访时间相对较短。
ISFD似乎是一种安全有效的LSS微创治疗方法。需要更大规模的随机对照试验来比较不同装置并完善手术技术。
