Department of Plastic & Reconstructive Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Research Institute of T&R Biofab Co., Ltd, Seongnam, Korea.
Yonsei Med J. 2024 Aug;65(8):456-462. doi: 10.3349/ymj.2023.0444.
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.
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.
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.
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).
外耳重建一直是整形外科医生几十年来面临的挑战。使用自体肋软骨或聚乙烯的流行方法仍然存在缺点。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法引起了关注。这是一项使用 3D 打印支架进行耳朵重建的临床试验，在 1 年后呈现了临床结果。
2021 年至 2022 年，5 名单侧小耳畸形的成年患者接受了两期 3D 打印植入物全耳重建。为每位患者，根据计算机断层扫描图像，使用基于聚己内酯（PCL）的熔丝制造（FFF）设计并制作了患者特异性 3D 打印支架。在术前、术后 2 周内和 1 年后进行计算机断层扫描扫描，以比较正常侧和重建耳朵的体积。在 1 年就诊时，由两名外科医生和患者本人对临床照片进行评分。
所有 5 名患者在 1 年随访时均完全治愈重建耳。平均而言，重建耳的体积为正常侧耳的 161.54%。客观评估者的评分在 0 到 10 之间为 3 到 6，而患者的评分为 8 到 10。
使用 3D 打印 PCL 植入物进行外耳重建，在 1 年后表现出持久、安全的效果，反映出体积恢复和患者满意度高。预计将进一步进行更多病例的临床随访，并通过先进的生物打印技术改进支架。该研究的计划和结果已在临床研究信息服务（CRIS No. 3-2019-0306）和食品和药物安全部（MFDS No. 1182）注册。
