Antimicrobial Biodegradable Bone Graft for Craniofacial/Maxillofacial Application

用于颅面/颌面应用的抗菌可生物降解骨移植物

基本信息

批准号：
9352308
负责人：
JASON E BURNS
金额：
$ 68.87万
依托单位：
N2 BIOMEDICAL, LLC
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-20 至 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9352308
关键词：
Absorbable Implants Alloys Anti-Bacterial Agents Antibiotics Biological Body Fluids Bone Growth Bone Transplantation California Ceramics Chemicals Clinical Defect Devices Equipment Excision Face Gentamicins Growth HA coating Health Care Costs Hydroxyapatites Immersion Investigative Technique Implant In Vitro Incidence Industry Infection prevention Lead Magnesium Mandible Maxilla Mechanics Metals Modeling Modification Operative Surgical Procedures Orthopedic Fixation Devices Orthopedic Surgery procedures Orthopedics Osseointegration Outcome Pain Patients Pediatric Surgical Procedures Performance Phase Polyesters Polyglycolic Acid Polymers Procedures Process Production Property Rattus Research Schedule Services Site Source Stainless Steel Surface Surgical complication Surgical sutures System Temperature Testing Thinness Tissues Titanium Universities Vertebral column antimicrobial base biomaterial compatibility bone clinically relevant cold temperature commercialization copolymer cost craniofacial craniomaxillofacial healing improved in vivo interest maxillofacial mechanical properties operation particle acceleration poly-L-lactic acid programs research and development sample fixation success surgery material

项目摘要

Project Summary Magnesium (Mg) and its alloys have attracted increasing interest for use as biodegradable implants, such as fixation devices for orthopedic and cranio-maxillofacial surgeries, due to their promising mechanical and biological properties, as well as their ability to degrade and resorb in the body. The overall aim of the Phase II program is to extend encouraging Phase I results in which biodegradable magnesium beads, coated with hydroxyapatite (HA) with an incorporated antibiotic, showed significant reduction of bacterial growth-rate and retained their mechanical properties during extended immersion in simulated body fluid. Uncoated controls lost much of their mechanical strength during the immersion tests. Phase II will extend the promising results by optimizing the hydroxyapatite coating, which is applied by N2 Biomedical's proprietary process to produce a thin, durable layer at low temperature, thereby retaining the properties of the HA source material and viability of temperature-sensitive material, such as an antibiotic. We will continue to develop a coating in which the HA will not only help initiate bone growth but also regulate the dissolution rate of the magnesium substrate and the release of the antibiotic, thus preventing infection. In vivo studies will use optimized HA-coated Mg implants in a rat model to study initiation of bone-growth, implant dissolution, and antibacterial efficacy of the antibiotic that is incorporated in the coating. Success of this program could lead to reduction or elimination of the present need for a subsequent operation to remove an implant or beads from the patient. Overall success through Phase III commercialization could start a revolution in the implant industry and a significant shift of the clinical paradigm in craniofacial and orthopedic surgery by reducing cost and pain associated with revision surgeries for implant removal.

项目摘要镁（MG）及其合金吸引了用作可生物降解植入物的兴趣，例如由于其有前途的机械和生物学特性及其在体内降解和质量的能力。第二阶段的总体目的程序将扩展令人鼓舞的第一阶段结果，其中可生物降解的镁珠涂有涂层羟基磷灰石（HA）具有掺入的抗生素，显示细菌生长速率的显着降低和在模拟体液中浸入浸入期间，保留了其机械性能。未涂层的控件丢失了他们在浸入测试中的大部分机械强度。第二阶段将通过优化羟基磷灰石涂料，该涂层由N2生物医学专有过程应用低温下薄耐用的层，从而保留了HA源材料的特性和生存能力温度敏感的材料，例如抗生素。我们将继续开发出HA将会的涂层不仅有助于启动骨骼生长，还可以调节镁基材的溶解速率和释放抗生素，从而防止感染。体内研究将使用优化的HA涂层MG植入物研究抗生素的骨骼生长，植入物溶解和抗菌功效的大鼠模型被掺入涂料中。该计划的成功可能导致减少或消除当前需要随后的操作从患者那里去除植入物或珠子。整体成功第三阶段的商业化可能会在植入物行业发生革命，并发生临床的重大转变通过减少与修订手术相关的成本和疼痛，颅面和骨科手术的范式用于去除植入物。