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

用于直接骨骼附着的深孔经皮塔的大型动物研究

• 批准号: 9359990
• 负责人: Mark Pitkin
• 金额: $ 77.85万
• 依托单位: POLY-ORTH INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-26 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9359990
• 关键词: American; Amputees; Animals; Bone Tissue; Boston; Cell Adhesion; Cells; Characteristics; Clinical Protocols; Clinical Research; Code; Communication; Country; Custom; Data; Devices; Eligibility Determination; Ensure; Epithelial Cells; Family suidae; Feasibility Studies; Foundations; Funding; Gait; Histopathology; Human; Implant; Infection; Institutes; International; Legal patent; Limb Prosthesis; Mechanics; Medical Device; Movement; Osseointegration; Outcome; Patients; Permeability; Phase; Porosity; Prosthesis; Prosthesis Failure; Prosthetic rehabilitation; Public Health; Recommendation; Regulation; Reliability of Results; Research; Research Personnel; Residual state; Resistance to infection; Risk; Safety; Series; Skin; Skin Tissue; Small Business Innovation Research Grant; Structure; System; Technology; Testing; Tissues; Titanium; Translations; Trauma; United States National Institutes of Health; War; Work; bone; commercialization; cost; design; implantable device; implantation; improved; innovation; limb amputation; manufacturing process; meetings; novel; phase 1 study; phase 2 study; preclinical study; prosthetic socket; prototype; response; risk minimization; safety testing; skeletal

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.

Poly-Orth International的研究成果证明了这部小说的可行性 “残余物-整体修复体技术”在下颌骨直接附着体中的应用 假肢。该技术包括一种“皮肤和骨骼一体化塔架”(SBIP)， 它将残肢与外肢假体连接起来，特别是 有益于不能使用传统插座附着式假体的患者。 正如对小动物研究后的组织病理学分析所表明的那样， SBIP不仅与残骨结合，而且与残骨皮肤结合 将感染和二次创伤的风险降至最低。调查人员开发了一种 优化的多孔钛基质及皮骨一体化支架的设计 最大限度地增加残骨的骨和皮肤细胞向SBIP的内长，而不需要 影响植入装置的强度。关于该工艺的技术研究 制造具有可渗透内部强化的复合多孔结构 框架。SBIP规范的参数受美国专利#8257435保护。 在拟议的转化性临床前研究期间，动物试验将 根据FDA的要求进行，以确保顺利过渡到试验 在人类身上。它将包括大型动物和长达22个月的种植期。