Preoperative Simulation and Three-Dimensional Model for the Operative Treatment of Tibiofibular Diaphyseal Fracture: A Randomized Controlled Clinical Trial.
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Abstract
Background: In order to ascertain the safety and therapeutic efficacy of preoperative simulation in conjunction with three-dimensional (3D) printing modalities for the surgical management of tibiofibular diaphyseal fractures. We postulate that preoperative simulation and three-dimensional (3D) printing techniques have a significant impact on reducing the mean operative time, diminishing intraoperative blood loss, and decreasing the frequency of fluoroscopic.
Material and methods: Sixty patients with tibiofibular diaphyseal fracture were divided into the conventional surgery group (n = 30) and the 3D printing group (n = 30). In the 3D printing group, preoperative equal-ratio fracture models prepared using the 3D printing technique were used to perform preoperative simulation, guide the real surgical operation, examine implant reduction and placement as well as preoperative plate/screw size. The operation time, intraoperative bleeding, frequency of fluoroscopies, Visual Analog Scale (VAS), and Johner-Wruhs Scale were recorded.
Results: The operation time, blood loss, and the frequency of fluoroscopy during operation in the group with preoperative simulation and 3D printing were less than that in the conventional surgery group (p < 0.001). Meanwhile, the Visual Analog Scale (VAS) and Johner-Wruhs Scale were also improved in both groups.
Conclusion: The findings indicated that preoperative simulation and three-dimensional (3D) printing may facilitate the treatment of tibiofibular diaphyseal fractures, potentially enhancing preoperative planning and contributing to the precision and personalization of the surgical procedure. Thus, the application of this technology possesses considerable promise for future utilization in clinical practice.
Trial registry: Name of the registry: This study was registered in the Chinese Clinical Trial Registry; Trial registration number: ChiCTR2100052379.
背景：为了确定术前模拟结合三维（3D）打印模式在胫腓骨骨骺骨折手术治疗中的安全性和治疗效果。我们推测，术前模拟和三维（3D）打印技术对缩短平均手术时间、减少术中失血和降低透视频率有显著影响：将60例胫腓骨二骺骨折患者分为传统手术组（30例）和3D打印组（30例）。3D打印组采用3D打印技术制作术前等比例骨折模型，进行术前模拟，指导实际手术操作，检查植入物的缩小和放置以及术前钢板/螺钉的尺寸。记录了手术时间、术中出血量、透视次数、视觉模拟量表（VAS）和 Johner-Wruhs 量表：结果：术前模拟组和 3D 打印组的手术时间、术中出血量和透视次数均少于常规手术组（P研究结果表明，术前模拟和三维（3D）打印可促进胫腓骨二骺骨折的治疗，有可能加强术前规划，有助于手术过程的精确性和个性化。因此，这项技术的应用在未来的临床实践中大有可为：登记处名称：本研究已在中国临床试验注册中心注册；试验注册号：ChiCTR2100052379：ChiCTR2100052379。
期刊介绍：
Journal of Investigative Surgery publishes peer-reviewed scientific articles for the advancement of surgery, to the ultimate benefit of patient care and rehabilitation. It is the only journal that encompasses the individual and collaborative efforts of scientists in human and veterinary medicine, dentistry, basic and applied sciences, engineering, and law and ethics. The journal is dedicated to the publication of outstanding articles of interest to the surgical research community.
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