创伤后鼻锥重建采用定制钛植入物：一例附超微结构评估的病例报告

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中文摘要

背景/目的： 对于严重畸形且自体移植材料选择已耗尽的患者，创伤后鼻锥重建具有挑战性，尤其是在多次手术失败后。定制钛植入物可能提供精确的结构支撑，但关于其在鼻重建中的黏膜整合及超微组织结构反应的数据尚缺乏。本研究旨在描述据我们所知首例使用IPS（个体化患者解决方案）定制钛植入物进行鼻锥重建的病例，并通过透射电子显微镜（TEM）评估植入物周围组织反应。方法：一名50岁男性军人，长期鞍鼻畸形、鼻塞，既往基于移植物的重建手术失败，接受开放式鼻整形术，置入根据既定鼻人体测量参数通过三维虚拟手术规划设计的患者特异性钛植入物，并依据欧盟法规(EU) 2017/745作为定制器械制造。该植入物重建了从鼻根到鼻尖的鼻背，并用皮质螺钉固定；另用一块薄钛板支撑鼻尖。术后24个月获取鼻黏膜及邻近结缔组织活检，进行TEM处理以评估上皮、基质、血管及植入物-组织界面特征。结果：临床上，去除填塞物后鼻气道通畅性立即改善，鼻轮廓恢复，24个月随访时功能和美学结果稳定，无并发症。超微结构上，呼吸上皮显示分层保留，基底细胞和纤毛细胞完整，细胞核和线粒体正常，细胞外基质有序且与离散钛颗粒紧密相邻，无肉芽肿性异物反应、密集炎症浸润或纤维性包裹。局灶性纤毛损伤、胞质空泡化、固有层增厚及血管弹性层重塑被解释为适应性或暂时性应激相关改变，而非慢性植入物毒性。结论：在基于移植物手术失败后的复杂创伤后鼻锥重建中，定制IPS钛植入物可提供稳定的结构支撑、满意的功能和美学结果以及耐受良好的黏膜界面。超微结构发现与植入物在24个月时良好的局部耐受性一致，主要显示上皮和基质结构保留，仅有局灶性、适应性应激相关改变，而非慢性植入物相关毒性。然而，由于这是单例病例，且未采用常规组织学、免疫组化或鼻气流客观测量进行评估，这些观察结果不能确立生物相容性、有效性或长期安全性，需要在更大系列和更长随访中加以证实。

英文摘要

Background/Objectives: Post-traumatic nasal pyramid reconstruction is challenging in patients with severe deformity and exhausted autologous graft options, particularly after multiple failed surgeries. Custom-made titanium implants may offer precise structural support, but data on their mucosal integration and ultrastructural tissue response in nasal reconstruction are lacking. The aim of this study is to describe what is, to the best of our knowledge, the first reported case of nasal pyramid reconstruction using an IPS (Individual Patient Solutions) custom-made titanium implant and to evaluate peri-implant tissue response with transmission electron microscopy (TEM). Methods: A 50-year-old male military personnel with long-standing saddle-nose deformity, nasal obstruction, and prior failed graft-based reconstructions underwent open rhinoplasty with placement of a patient-specific titanium implant designed with three-dimensional virtual surgical planning on the basis of established nasal anthropometric parameters and manufactured as a custom-made device under Regulation (EU) 2017/745. The implant reconstructed the nasal dorsum from nasion to tip and was stabilized with cortical screws; an additional thin titanium plate was used for tip support. Biopsies of nasal mucosa and adjacent connective tissue obtained 24 months postoperatively were processed for TEM to assess epithelial, stromal, vascular, and implant-tissue interface characteristics. Results: Clinically, nasal airway patency improved immediately after packing removal, with restoration of nasal contour and stable functional and aesthetic outcomes at 24-month follow-up without complications. Ultra-structurally, the respiratory epithelium showed preserved stratification, intact basal and ciliated cells, normal nuclei and mitochondria, and organized extracellular matrix closely opposed to discrete titanium particles, without granulomatous foreign-body reaction, dense inflammatory infiltrate, or fibrotic encapsulation. Focal ciliary damage, cytoplasmic vacuolization, lamina propria thickening, and vascular elastic lamina remodeling were interpreted as adaptive or transient stress-related changes rather than chronic implant toxicity. Conclusions: Custom-made IPS titanium implants can provide stable structural support, satisfactory functional and aesthetic outcomes, and a well-tolerated mucosal interface in complex post-traumatic nasal pyramid reconstruction after failed graft-based surgeries. The ultrastructural findings are being consistent with good local tolerance of the implant at 24 months, showing predominantly preserved epithelial and stromal architecture with only focal, adaptive stress-related changes rather than chronic implant-related toxicity. However, as this is a single case assessed without conventional histology, immunohistochemistry or objective measurement of nasal airflow, these observations cannot establish biocompatibility, efficacy or long-term safety, and require confirmation in larger series with longer follow-up.