Abstract：
This study investigates the safety and efficacy of 3D-printed polycaprolactone/hydroxyapatite (PCL/HA) scaffolds for patient-specific cranioplasty surgeries, employing liquid deposition modeling (LDM) technology. This research is pioneering as it explores the impact of gamma radiation on PCL/HA scaffolds and utilizes printing ink with the highest content of HA known in the composite. The mechanical, morphological, and macromolecular stability of the gamma-sterilized scaffolds were verified before implantation. Subsequent research involving animal subjects was conducted to explore the effects of sterilized implants. Eventually, three clinical cases were selected for the implantation studies as part of a phase 1 non-randomized open-label clinical trial. It was shown that a 25 kGy gamma-ray dose for sterilizing the printed implants did not alter the required geometrical precision of the printed implants. The implants exhibited well-distributed HA and strength comparable to cancellous bone. Gamma radiation reduced hydrophobicity and water uptake capacity without inducing pyrogenic or inflammatory responses. Personalized PCL/HA substitutes successfully treated various craniomaxillofacial defects, including trauma-induced facial asymmetry and congenital deformities. HA nanoparticles in the ink stimulated significant osteoconductive responses within three months of implantation. Moreover, the results revealed that while larger implants may exhibit a slower bone formation response in comparison to smaller implants, they generally had an acceptable rate and volume of bone formation. This clinical trial suggests the application of a sterilized PCL/HA composite for craniomaxillofacial surgery is safe and could be considered as a substitute for autologous bone.
摘要：
这项研究调查了3D打印聚己内酯/羟基磷灰石（PCL/HA）支架用于患者特定颅骨成形术的安全性和有效性，采用液相沉积建模(LDM)技术。这项研究是开创性的，因为它探索了γ辐射对PCL/HA支架的影响，并利用了复合材料中HA含量最高的印刷油墨。机械的,形态学,植入前验证了γ灭菌支架的大分子稳定性。随后进行涉及动物受试者的研究以探索灭菌植入物的效果。最终,作为1期非随机开放标签临床试验的一部分,我们选择了3例临床病例进行植入研究.结果表明，用于对印刷植入物进行灭菌的25kGy伽马射线剂量不会改变印刷植入物所需的几何精度。植入物表现出分布良好的HA和与松质骨相当的强度。γ辐射降低疏水性和水吸收能力而不诱导热原或炎症反应。个性化PCL/HA替代品成功治疗各种颅颌面缺损，包括外伤引起的面部不对称和先天性畸形。墨水中的HA纳米颗粒在植入后三个月内刺激了明显的骨传导反应。此外，结果显示，虽然与较小的植入物相比，较大的植入物可能表现出较慢的骨形成反应，它们通常具有可接受的骨形成速率和体积。该临床试验表明，将灭菌的PCL/HA复合材料用于颅颌面手术是安全的，可以被认为是自体骨的替代品。
