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，可以使用标准护理X射线成像检测和监测髋关节感染。髋 全世界每年有数百万人接受置换手术。仅在美国， 每年进行45万例全髋关节置换术。大多数手术都很成功， 并发症然而，感染是失败的主要原因，其发生率约为总发生率的0.5- 2 髋关节置换手术如果及早发现，这些感染可以及时用抗生素治疗， 外科清创术。然而，成熟的生物膜通常需要移除植入物来治疗感染， 翻修手术，伴随着发病率、死亡率和高额费用的风险。因此，重要的是 及早发现手术后感染，并监测治疗效果，以便进行有效治疗。我们有 开发了一种新型的pH指示传感器，可以连接到假体上，可以测量局部感染，并可以 使用标准X射线进行定量。本阶段I SBIR将这些pH指示传感器应用于股骨- 颈部髋关节假体，并评估其效用在绵羊模型。我们的长期目标是发展第一个 使用普通X线摄影进行非侵入性局部pH测量的设备。进一步发展可以 请参阅集成到植入物中的传感器，并进行进一步的商业化合作。我们的科学前提是 体内酸中毒可以通过使用pH指示装置的常规放射照相术非侵入性地测量， 使用对氢离子的存在有机械响应的水凝胶制造。初步研究 在预期的生理pH范围内显示足够的响应速率和pH敏感性。我们将完善 体外和人体尸体模型原型，并使用动物髋关节验证传感器的体内功能 羊的模型这项研究意义重大，因为它开发了一种非侵入性的方法来检测， 监测和研究原位感染，最终有可能降低发病率、死亡率和相关风险。 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.