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.

多恩国际的研究工作表明了小说的可行性 用于直接骨骼附件 肢体假肢。该技术包括“皮肤和骨骼整合塔”（SBIP）， 将残留物与外部肢体假体连接起来，尤其是 对无法使用伪造的传统插座附着的患者有益。 作为研究后的组织病理学分析证明了 SBIP不仅与残留的骨头整合在一起，而且还与残留的皮肤整合在一起 最大程度地减少感染和继发性创伤的风险。调查人员开发了一个 最佳的多孔钛基质和皮肤和骨骼整合塔的设计 最大化残留物的骨头和皮肤细胞向SBIP最大化 损害植入装置的强度。该过程的技术研究 由可渗透内部强制执行的复合多孔结构的制造 框架。 SBIP规范的参数受美国专利＃8257435的保护。 在拟议的翻译前研究中，动物试验将是 根据FDA要求进行的，以确保平稳翻译为试验 在人类中。它将包括大型动物和长达22个月的植入期。