Large animal study on deeply porous transcutaneous pylon for direct skeletal attachment

Poly-Orth International的研究工作证明了小说的可行性 “残体整合修复技术”将用于直接骨骼附着， 假肢该技术包括一个“皮肤和骨骼集成支架”（SBIP）， 其将残肢与外部假肢连接起来，特别是 对于不能使用传统的假体窝附着的患者是有益的。 如小动物研究后的组织病理学分析所示， SBIP不仅与残骨结合，而且与残骨皮肤结合 最大限度地减少感染和二次创伤的风险。研究人员开发了一种 最佳多孔钛基质和皮骨一体化支架的设计， 最大限度地增加残余物的骨和皮肤细胞向SBIP的向内生长， 损害植入装置的强度。工艺研究 制造具有可渗透内部结构的复合多孔结构 frame. SBIP规范的参数受美国专利#8257435保护。 在拟定的转化临床前研究期间，将进行动物试验 根据FDA要求进行，以确保顺利转化为试验 在人类身上。它将包括大型动物，植入期长达22个月。

Research efforts of the Poly-Orth International demonstrated feasibility of the novel “Residuum-Integration Prosthetic Technology" to be used in direct skeletal attachment of limb prosthetics. The technology includes a “Skin and Bone Integrated Pylon” (SBIP), which connects the residuum with external limb prosthesis and can be especially beneficial for patients who can not use traditional socket attachment of the prostheses. As histopathology analysis after the study with small animals has demonstrated, the SBIP is integrated not only with the residual bone, but also with the residuum's skin minimizing the risk of infection and secondary trauma. The investigators developed an optimal porous titanium matrix and design of the Skin and Bone Integrated Pylon to maximize the ingrowth of bone and skin cells of the residuum to the SBIP without compromising strength of the implanted device. The technological study on the process of manufacturing of the composite porous structure enforced with a permeable internal frame. Parameters of the SBIP's specification are protected by the US Patent #8257435. During the proposed translational pre-clinical study the animal trials will be conducted according to the FDA requirements to ensure smooth translation to the trials in humans. It will include large animals and the implantation period up to 22 months.