Department of Surgery, Isala Hospital, 8000 GK, Zwolle, The Netherlands.
Department of Robotics and Mechatronics, Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, P.O. Box 217, 7500 AE, Enschede, The Netherlands.
Arch Orthop Trauma Surg. 2021 Nov;141(11):1899-1907. doi: 10.1007/s00402-020-03654-6. Epub 2020 Oct 31.
Due to the variation in shape and curvature of the clavicle, plates often have to be adjusted during surgery to acquire a good fit. Poorly fitted plates can cause discomfort, eventually requiring implant removal. 3D-printed replicas of the fractured clavicle can assist in planning of the surgical approach, plate selection and, if necessary, adjustment of the plate prior to surgery. We hypothesized this method of preoperative preparation would reduce implant-related discomfort resulting in a reduced reoperation rate MATERIALS AND METHODS: In a prospective cohort study, perioperative plate handling and clavicle fixation were timed and follow-up data were collected from participants undergoing operative treatment for a midshaft clavicle fracture. The control group (n = 7) received conventional surgery with standard precontoured plates. For the intervention group (n = 7), 3D-printed replicas of the fractured clavicle and a mirrored version of the healthy contralateral clavicle were available prior to surgery for planning of the surgical approach, and for plate selection and contouring. Primary outcome was reoperation rate due to implant-related discomfort. Secondary outcomes were complications and time differences in the different surgical phases (reduction, fixation and overall operation time) RESULTS: More participants in the control group had the plate removed due to discomfort compared to the intervention group (5/7 vs. 0/6; P = 0.012). One participant was excluded from the intervention group due to a postoperative complication; an infection occurred at the implant site. No relevant time difference in surgical plate handling was found between both groups.
Preoperative preparation using 3D-printed replicas of the clavicle fracture may reduce implant removal caused by plated-related discomfort. No relevant effect on surgery time was found.
Registered with 'toetsingonline.nl', trial number NL51269.075/14, 17-02-2015.
由于锁骨的形状和曲率存在差异，因此在手术中经常需要调整钢板以使其贴合良好。如果钢板贴合不良，会引起不适，最终可能需要取出植入物。3D 打印的锁骨骨折模型有助于规划手术入路、选择钢板，如果需要，还可以在手术前对钢板进行调整。我们假设这种术前准备方法可以减少与植入物相关的不适，从而降低再次手术的发生率。
在一项前瞻性队列研究中，对接受手术治疗的锁骨中段骨折患者进行手术中钢板处理和锁骨固定的计时，并收集患者的随访数据。对照组（n=7）接受常规手术和标准预塑形钢板治疗。对于干预组（n=7），在手术前提供了骨折锁骨的 3D 打印模型和对侧健康锁骨的镜像，以便规划手术入路、选择和塑形钢板。主要结局是因植入物相关不适而导致的再次手术率。次要结局是并发症和不同手术阶段（复位、固定和总手术时间）的时间差异。
与干预组相比，对照组因不适而取出钢板的患者更多（5/7 比 0/6；P=0.012）。由于术后并发症（感染发生在植入物部位），干预组有 1 名患者被排除。两组在手术中处理钢板的时间上没有明显差异。
使用锁骨骨折 3D 打印模型进行术前准备可能会减少因钢板相关不适而导致的植入物取出。未发现对手术时间有相关影响。
在“toetsingonline.nl”注册，试验编号 NL51269.075/14，2015 年 2 月 17 日。
