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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

基本信息

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
项目类别：
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

项目摘要

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.

保利北国际的研究工作证明了小说的可行性