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).
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).