PDF(Pubmed)
Abstract：
OBJECTIVE: External ear reconstruction has been a challenging subject for plastic surgeons for decades. Popular methods using autologous costal cartilage or polyethylene still have their drawbacks. With the advance of three-dimensional (3D) printing technique, bioscaffold engineering using synthetic polymer draws attention as an alternative. This is a clinical trial of ear reconstruction using 3D printed scaffold, presented with clinical results after 1 year.
METHODS: From 2021 to 2022, five adult patients with unilateral microtia underwent two-staged total ear reconstruction using 3D printed implants. For each patient, a patient-specific 3D printed scaffold was designed and produced with polycaprolactone (PCL) based on computed tomography images, using fused deposition modeling. Computed tomography scan was obtained preoperatively, within 2 weeks following the surgery and after 1 year, to compare the volume of the normal side and the reconstructed ear. At 1-year visit, clinical photo was taken for scoring by two surgeons and patients themselves.
RESULTS: All five patients had completely healed reconstructed ear at 1-year follow-up. On average, the volume of reconstructed ear was 161.54% of that of the normal side ear. In a range of 0 to 10, objective assessors gave scores 3 to 6, whereas patients gave scores 8 to 10.
CONCLUSIONS: External ear reconstruction using 3D printed PCL implant showed durable, safe results reflected by excellent volume restoration and patient satisfaction at 1 year postoperatively. Further clinical follow-up with more cases and refinement of scaffold with advancing bioprinting technique is anticipated. The study\'s plan and results have been registered with the Clinical Research Information Service (CRIS No. 3-2019-0306) and the Ministry of Food and Drug Safety (MFDS No. 1182).
METHODS: From 2021 to 2022, five adult patients with unilateral microtia underwent two-staged total ear reconstruction using 3D printed implants. For each patient, a patient-specific 3D printed scaffold was designed and produced with polycaprolactone (PCL) based on computed tomography images, using fused deposition modeling. Computed tomography scan was obtained preoperatively, within 2 weeks following the surgery and after 1 year, to compare the volume of the normal side and the reconstructed ear. At 1-year visit, clinical photo was taken for scoring by two surgeons and patients themselves.
RESULTS: All five patients had completely healed reconstructed ear at 1-year follow-up. On average, the volume of reconstructed ear was 161.54% of that of the normal side ear. In a range of 0 to 10, objective assessors gave scores 3 to 6, whereas patients gave scores 8 to 10.
CONCLUSIONS: External ear reconstruction using 3D printed PCL implant showed durable, safe results reflected by excellent volume restoration and patient satisfaction at 1 year postoperatively. Further clinical follow-up with more cases and refinement of scaffold with advancing bioprinting technique is anticipated. The study\'s plan and results have been registered with the Clinical Research Information Service (CRIS No. 3-2019-0306) and the Ministry of Food and Drug Safety (MFDS No. 1182).
摘要：
目的：几十年来，外耳重建一直是整形外科医生的挑战性课题。使用自体肋软骨或聚乙烯的流行方法仍然有其缺点。随着三维（3D）打印技术的进步，使用合成聚合物的生物支架工程作为替代方案引起了人们的注意。这是一项使用3D打印支架重建耳朵的临床试验，1年后的临床结果。
方法：从2021年到2022年，五名单侧小耳畸形的成年患者使用3D打印植入物进行了两阶段全耳重建。对于每个病人来说,基于计算机断层扫描图像，使用聚己内酯（PCL）设计并生产了患者特定的3D打印支架，使用熔融沉积建模。术前获得计算机断层扫描，手术后2周内和1年后，比较正常侧和重建耳朵的体积。在为期一年的访问中，由两名外科医生和患者自己拍摄临床照片进行评分。
结果：在1年的随访中，所有5例患者的耳朵完全愈合。平均而言,重建耳的体积是正常侧耳的161.54％。在0到10的范围内，客观评估者的评分为3到6，而患者的评分为8到10。
结论：使用3D打印的PCL植入物进行外耳重建显示出持久，安全结果反映在术后1年出色的容量恢复和患者满意度.预计会有更多病例的进一步临床随访，并通过先进的生物打印技术改善支架。该研究的计划和结果已在临床研究信息服务处注册（CRIS编号。3-2019-0306)和食品药品安全部(MFDSNo.1182).
方法：从2021年到2022年，五名单侧小耳畸形的成年患者使用3D打印植入物进行了两阶段全耳重建。对于每个病人来说,基于计算机断层扫描图像，使用聚己内酯（PCL）设计并生产了患者特定的3D打印支架，使用熔融沉积建模。术前获得计算机断层扫描，手术后2周内和1年后，比较正常侧和重建耳朵的体积。在为期一年的访问中，由两名外科医生和患者自己拍摄临床照片进行评分。
结果：在1年的随访中，所有5例患者的耳朵完全愈合。平均而言,重建耳的体积是正常侧耳的161.54％。在0到10的范围内，客观评估者的评分为3到6，而患者的评分为8到10。
结论：使用3D打印的PCL植入物进行外耳重建显示出持久，安全结果反映在术后1年出色的容量恢复和患者满意度.预计会有更多病例的进一步临床随访，并通过先进的生物打印技术改善支架。该研究的计划和结果已在临床研究信息服务处注册（CRIS编号。3-2019-0306)和食品药品安全部(MFDSNo.1182).
