Phase II year
2016
(last award dollars: 2017)
Phase II Amount
$1,399,561
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.
Public Health Relevance Statement: Inadequate prosthetic rehabilitation after limb amputation is a serious problem relevant to public health. The public value of solving this serious problem is much more elevated when a country is at war. Providing US amputees with infection-safe and long-lasting direct skeletal attachment of prostheses will improve the quality of their lives and eliminate the costs associated with the multiple fabrications adjustments and frequent failures of the prosthetic sockets.
Project Terms: American; Amputees; Animals; bone; Bone Tissue; Boston; Cell Adhesion; Cells; Characteristics; Clinical Protocols; Clinical Research; Code; commercialization; Communication; cost; Country; Custom; Data; design; Devices; Eligibility Determination; Ensure; Epithelial Cells; Failure; Family suidae; Feasibility Studies; Foundations; Funding; Gait; Histopathology; Human; Implant; implantable device; implantation; improved; Infection; innovation; Institutes; International; Legal patent; limb amputation; Limb Prosthesis; manufacturing process; Marketing; Medical Device; meetings; Movement; novel; Osseointegration; Outcome; Patients; Phase; phase 1 study; phase 2 study; Porosity; preclinical study; Prostheses and Implants; Prosthesis; Prosthetic rehabilitation; prosthetic socket; prototype; Public Health; Recommendation; Regulation; Reliability of Results; Research; Research Personnel; Residual state; Resistance to infection; response; Risk; Safety; safety testing; secondary infection; Series; skeletal; Skin; Skin Tissue; Small Business Innovation Research Grant; Structure; System; Technology; Testing; Tissues; Titania; Titanium; Translations; Trauma; United States National Institutes of Health; War; Work
