GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Eur Spine J. 2019 Jul;28(7):1712-1723. doi: 10.1007/s00586-019-05978-3. Epub 2019 Apr 20.
Screw misplacement incidence can be as high as 15-30% in spine deformity surgery, with possible devastating consequences. Some technical solutions to prevent misplacement require expensive devices. MySpine comprises a low-dose CT scan of the patient's spine to build a virtual model of the spine to plan the screw trajectories and a 3D-printed patient-specific guide system to prepare the screw trajectories and to implant the screws in the vertebrae in order to increase reproducibility and safety of the implants. The aim of this open-label, single-center, prospective randomized clinical trial with independent evaluation of outcomes was to compare the accuracy of free-hand insertion of pedicle screws to MySpine 3D-printed patient-specific guides.
Twenty-nine patients undergoing surgical correction for spinal deformity were randomized to Group A (pedicle screws implantation with MySpine) or Group B (free-hand implantation). Group A received 297 pedicle screws, and Group B 243 screws. Forty-three screws in Group A crossed over to free-hand implantation. Screw position was graded according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as "safe area." Total fluoroscopy dose and time were compared in six patients of each group.
Comparing the two study groups, we observed a statistically significant difference between the two groups (p < 0.05), with 96.1% of screws in the "safe area" in Group A versus a 82.9% in Group B. Group-A patients had a mean effective dose of 0.23 mSv compared to 0.82 mSv in Group B. Patient-specific, 3D-printed pedicle screw guides increase safety in a wide spectrum of deformity conditions. In addition, the total radiation dose is reduced, even considering the need of a low-dose preoperative CT for surgical planning.
I. These slides can be retrieved under Electronic Supplementary Material.
脊柱畸形手术中螺钉错位的发生率高达 15-30%，可能产生灾难性的后果。一些防止错位的技术解决方案需要昂贵的设备。MySpine 包括对患者脊柱进行低剂量 CT 扫描，以构建脊柱的虚拟模型来规划螺钉轨迹，并使用 3D 打印的患者特定导向系统来准备螺钉轨迹并将螺钉植入椎骨，以提高植入物的可重复性和安全性。本项开放性、单中心、前瞻性随机临床试验的目的是独立评估结果，比较徒手置入椎弓根螺钉与 MySpine 3D 打印患者专用导板的准确性。
29 例接受脊柱畸形手术矫正的患者被随机分为 A 组（使用 MySpine 植入椎弓根螺钉）或 B 组（徒手植入）。A 组共植入 297 枚螺钉，B 组共植入 243 枚螺钉。A 组中有 43 枚螺钉改为徒手植入。螺钉位置根据 Gertzbein 分级，0、A、B 或 C 级，0 或 A 级为“安全区”。比较每组 6 例患者的总透视剂量和时间。
比较两组研究结果，两组之间存在统计学差异（p<0.05），A 组 96.1%的螺钉位于“安全区”，B 组为 82.9%。A 组患者的平均有效剂量为 0.23mSv，而 B 组为 0.82mSv。患者专用 3D 打印椎弓根螺钉导板在广泛的畸形条件下提高了安全性。此外，即使考虑到手术计划需要进行低剂量术前 CT，总辐射剂量也会降低。
I. 这些幻灯片可在电子补充材料中获取。
