Park Han Byeol, Son Seong, Jung Jong Myung, Lee Sang Gu, Yoo Byung Rhae
Department of Neurosurgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
J Korean Neurosurg Soc. 2022 Sep;65(5):730-740. doi: 10.3340/jkns.2022.0028. Epub 2022 May 17.
Although several commercialized bone cements are used during percutaneous vertebroplasty (PVP) for patients with osteoporotic vertebral compression fracture (OVCF), there are no reports using domestic products from South Korea. In this study, we investigated the safety and efficacy of Spinofill® (Injecta Inc., Gunpo, Korea), a new polymethyl methacrylate product.
A prospective, single-center, and single-arm clinical trial of 30 participants who underwent PVP using Spinofill® for painful thoracolumbar OVCF was performed with 6-months follow-up. Clinical and surgical outcomes included the Visual analog scale (VAS), Korean-Oswestry disability index (K-ODI), and Odom's criteria, complication rate, and recurrence rate. Radiological outcomes were evaluated by measuring the findings of postoperative computed tomography and simple radiograph.
The pain of VAS (from 8.95±1.05 to 4.65±2.06, p<0.001) and the life quality based on K-ODI (from 33.95±5.84 to 25.65±4.79, p<0.001) improved significantly, and successful patient satisfaction were achieved in 20 patients (66.7%) 1 day after surgery. These immediate improvements were maintained or more improved during the follow-up. There was no surgery- or product-related complications, but OVCF recurred in two patients (6.7%). Favorable cement interdigitation was reported in 24 patients (80.0%), and extra-vertebral cement leakage was reported in 13 patients (43.0%). The mean vertebral height ratio (from 60.49%±21.97% to 80.07%±13.16%, p<0.001) and segmental kyphotic angle (from 11.46°±8.50° to 7.79°±6.08°, p=0.002) improved one day after surgery. However, these short-term radiological findings somewhat regressed at the end.
The overall outcomes of PVP using Spinofill® were as favorable as those of other conventionally used products.
尽管经皮椎体成形术（PVP）治疗骨质疏松性椎体压缩骨折（OVCF）患者时使用了几种商业化骨水泥，但尚无使用韩国国产产品的报道。在本研究中，我们调查了新型聚甲基丙烯酸甲酯产品Spinofill®（韩国金浦市Injecta公司）的安全性和有效性。
对30例因疼痛性胸腰椎OVCF接受使用Spinofill®进行PVP的参与者进行了一项前瞻性、单中心、单臂临床试验，并随访6个月。临床和手术结果包括视觉模拟量表（VAS）、韩国奥斯维斯特残疾指数（K-ODI）、奥多姆标准、并发症发生率和复发率。通过测量术后计算机断层扫描和简单X线片的结果来评估影像学结果。
VAS疼痛评分（从8.95±1.05降至4.65±2.06，p<0.001）和基于K-ODI的生活质量（从33.95±5.84降至25.65±4.79，p<0.001）显著改善，术后1天有20例患者（66.7%）获得了成功的患者满意度。这些即时改善在随访期间得以维持或进一步改善。没有与手术或产品相关的并发症，但有2例患者（6.7%）出现了OVCF复发。24例患者（80.0%）报告有良好的骨水泥相互交锁，13例患者（43.0%）报告有椎体外骨水泥渗漏。术后1天椎体平均高度比（从60.49%±21.97%提高到80.07%±13.16%，p<0.001）和节段后凸角（从11.46°±8.50°减小到7.79°±6.08°，p=0.002）有所改善。然而，这些短期影像学结果在最后有所消退。
使用Spinofill®进行PVP的总体结果与其他传统使用的产品一样良好。
