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

用于假体关节感染的 X 射线可视化植入传感器 (X-VIS-PJI)

基本信息

批准号：
10547368
负责人：
JEFFREY N ANKER
金额：
$ 30万
依托单位：
ARAVIS BIOTECH, LLC
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-07-15 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10547368
关键词：
Acidity Acidosis Animal Testing Animals Antibiotics Blood Businesses C-reactive protein Cadaver Calibration Carbomer-940 Catheters Cattle Chemicals Chronic Clinical Contracts Control Animal Debridement Development Devices Early Diagnosis Erythrocyte Sedimentation Rate Excision Failure Focal Infection Goals Health Care Costs Hip Prosthesis Hip region structure Histology Hour Human Hydrogels Implant In Situ In Vitro Incidence Infection Joint Prosthesis Joints Legal patent Life Liquid substance Location Measurement Measures Mechanics Methods Microbial Biofilms Modeling Monitor Morbidity - disease rate Neck Operative Surgical Procedures Optics Patients Performance Peritoneal Dialysis Persons Pharmaceutical Preparations Phase Physicians Physiological Positioning Attribute Property Prosthesis Protons Public Health Quality of life Rattus Reading Reporting Reproducibility Research Research Project Grants Resolution Risk Roentgen Rays Sampling Serum Services Sheep Small Business Innovation Research Grant Specimen Staphylococcus aureus infection Swelling Synovial Fluid Testing Thick Tissues Total Hip Replacement United States United States Agency for Healthcare Research and Quality Variant Work X-Ray Medical Imaging alpha-Defensins base clinically relevant commercialization cost design effective therapy feasibility testing follow-up hip replacement arthroplasty hydronium ion implantation implanted sensor improved in vivo inflammatory marker innovation joint infection mortality novel novel strategies prototype radiological imaging response sensor sensor technology sheep model standard of care

项目摘要

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.

抽象的我们的目标是制造和验证一种新型的pH指导传感器，该传感器可以与髋关节相连可以使用标准的CARE X射线成像检测和监测髋关节感染的集成传感器。时髦的每年在全球数百万人进行替换手术。仅在美国，每年进行450,000个总髋关节塑料。这些手术中的大多数都是成功的，没有并发症。但是，感染是失败的主要原因，大约占总数的约0.5-2％髋关节置换手术。如果早期检测到，这些感染可以用抗生素及时治疗手术调试。但是，成熟的生物膜通常需要去除植入物以治疗感染，然后通过修订手术，与发病率，死亡率和大费用相关的风险。因此，重要的是尽早检测手术后感染并监测疗法的有效治疗作用。我们有开发了可以附着在假体上的新型pH指示传感器，可以测量局部感染，并且可以使用标准X射线进行量化。此I阶段I SBIR将将这些pH指示传感器应用于股骨髋关节假体的颈部并在绵羊模型中评估其效用。我们的长期目标是开发第一个使用普通射线照相实现无创局部pH测量的设备。进一步的发展可能请参阅通过进一步的商业化合作伙伴关系集成到植入物中的传感器。我们的科学前提是可以使用pH指示装置的常规射线照相对体内酸中毒的体内进行测量使用水凝胶机械地响应氢离子的存在。初步研究在预期的物理pH范围内显示出足够的响应率和pH敏感性。我们将完善体外和人尸体模型的原型，并使用动物髋关节验证传感器的体内功能绵羊的模特。拟议的研究很重要，因为它开发了一种无创方法来检测，监测并原位研究感染，最终可能会降低发病率，死亡率和相关性植入感染的成本。