X-ray Visualized Implanted Sensor for Prosthetic Joint Infection (X-VIS-PJI)

摘要 我们的目标是制造和验证一种新型的pH指示传感器，它可以连接到髋关节假体上 集成传感器，可使用标准护理X射线成像检测和监控髋部感染。臀部 全球每年有数百万人接受替代手术。仅在美国， 每年有45万例全髋关节置换术。这些手术大多是成功的，没有 并发症。然而，感染是失败的主要原因，发病率约占总数的0.5%-2% 髋关节置换手术。如果及早发现，这些感染可以迅速用抗生素和 外科清创手术。然而，成熟的生物膜通常需要取出种植体来治疗感染，随后 通过翻修手术伴随着相关的发病率、死亡率和高昂的费用。因此，重要的是要 及早发现术后感染，监测治疗效果，进行有效治疗。我们有 开发了新型的pH指示传感器，这种传感器可以附着在假体上，可以测量局部感染，并且可以 使用标准的x射线进行量化。这一阶段的SBIR将把这些pH指示传感器应用于股骨- 假体的颈部，并在绵羊模型中评估其实用性。我们的长远目标是发展第一 能够使用普通射线照相术进行非侵入性局部PH值测量的设备。进一步的发展可能 看到传感器集成到植入物中，并进一步商业化合作。我们的科学前提是 体内的酸中毒可以通过使用pH指示装置的常规X光照相无创地测量 使用对氢离子的存在做出机械反应的水凝胶制成的。初步研究 表现出足够的响应率，并在预期的生理pH范围内对pH敏感。我们将完善 体外和人类身体模型的原型，并使用动物髋关节验证传感器在体内的功能 在羊身上做模特。这项拟议的研究具有重要意义，因为它开发了一种非侵入性方法来检测， 现场监测和研究感染，最终有可能降低发病率、死亡率和相关 植入物感染的成本。

Abstract Our goal is to fabricate and validate a novel pH-indicating sensor which can attach to a hip prosthesis with integrated sensors that can detect and monitor hip infections using standard of care X-ray imaging. Hip replacement surgeries are performed on millions of people worldwide each year. In the United States alone, there were 450,000 total hip arthroplasties performed annually. Most of these surgeries are successful with no complications. However, infections are a leading cause of failure, with an incidence of about ~0.5-2% of total hip replacement surgeries. If detected early, these infections can be treated promptly with antibiotics and surgical debridement. However, mature biofilms usually require implant removal to treat the infection, followed by revision surgery with associated risks of morbidity, mortality, and large cost. Therefore, it’s important to detect post-surgery infections early and monitor the effect of therapies for effective treatment. We have developed novel pH-indicating sensors which can attach to a prosthesis, can measure local infection, and can be quantified using a standard x-ray. This Phase I SBIR will apply these pH-indicating sensors to the femoral- neck of a hip prosthesis and evaluate their utility in a sheep model. Our long term goal is to develop the first device that enables noninvasive local pH measurements using plain radiography. Further development could see the sensor integrated into the implant with further commercialization partnership. Our scientific premise is that acidosis in vivo can be measured noninvasively by conventional radiography using a pH-indicating device fabricated using hydrogels that respond mechanically to the presence of hydrogen ions. Preliminary studies show sufficient response rate, and pH sensitivity in the expected physiological pH range. We will refine the prototype in vitro and human cadaver models, and validate the sensor in vivo function using an animal hip model in sheep. The proposed research is significant because it develops a noninvasive method to detect, monitor, and study infection in situ with the ultimate potential for reducing morbidity, mortality and associated cost from implant infections.