The X-VISUAL (X-ray Visualized Indicator for Screw-strain Under Applied Load)

X-VISUAL（施加负载下螺钉应变的 X 射线可视化指示器）

基本信息

批准号：
10822470
负责人：
John David DesJardins
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：
2023
资助国家：
美国
起止时间：
2023-09-25 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10822470
关键词：
Address Anatomy Body Weight Bone callus Cadaver Cannulations Caring Clinical Collaborations Communication Computer Models Day Surgery Device or Instrument Development Devices Excision Failure Fatigue Feedback Femur Finite Element Analysis Fracture Fracture Fixation Geometry Growth Health care facility Hip Fractures Hip region structure Hospital Mortality Human Image Image Analysis Implant Industry Interobserver Variability Intertrochanteric Fractures Intervention Intramedullary Nailing Lead Legal patent Length Life Expectancy Location Measurement Measures Mechanics Medical Device Designs Methodology Methods Modeling Morbidity - disease rate Morphology Motion Nail plate Operative Surgical Procedures Optics Orthopedic Surgery Orthopedics Osteoporosis Outcome Pathology Patient Readmission Patients Pelvis Periodicity Phase Physicians Positioning Attribute Postoperative Period Procedures Public Health Quality of life Radiology Specialty Recording of previous events Research Research Project Grants Risk Roentgen Rays Sales Second Look Surgery Sheep Slide Small Business Innovation Research Grant Specimen Surveys System Techniques Testing Time Traction Trochanters Visual Weight Weight-Bearing state Work X ray visualization X-Ray Medical Imaging arm biomechanical test bone bone fracture repair bone healing clinical predictors clinical translation clinically relevant comorbidity cost design fracture risk healing human old age (65+)human tissue imaging modality improved individual patient individualized medicine innovation manufacture mechanical device mortality novel operation patient mobility patient population physical therapist prevent prototype radiological imaging response sample fixation sensor simulation standard of care time use

项目摘要

ABSTRACT We are developing and sensor, the X-VISUAL (X-ray Visualized Indicator for Screw bending Under Applied Load), to track fracture healing in canulated screws used to treat hip fractures. Hip fractures are a major public health concern with high in-hospital mortality rate. Approximately 330,000 hip fixation procedures are performed annually in the US. The average hip fixation hardware failure rate is around 5%, but increases to over 20% in patients with comorbidities such as osteoporosis, unstable fractures and poor initial fracture reduction. When healing is delayed, the screw, other hardware, and bone can fatigue and fail, requiring costly revision surgery with significant risk of morbidity and mortality for these frail patients. For example, the 1-year all-cause mortality rate for patients readmitted within 30 days of surgery is 56%, compared to 19% for those not readmitted. Screws only bend and cutout when they are loaded, and this risk disappears as a fracture callus heals and carries the load. Thus, measuring screw bending under standing load is an ideal way to assess fracture healing and risk failure. This improves communications with the patient and care team, enabling normally healing patients and physical therapists to feel more comfortable with activity, while detecting and avoiding pathologies for slowly healing patients. Innovatively, the X-VISUAL is the first sensor that can detect screw bending (and associated load on the screw), a measurement that is hard to perform in other ways because of the confined geometry. The patent protected device is designed to load into a screw after guidewire removal, and is read using plain radiography which is ubiquitously available in healthcare facilities but is usually insensitive to mechanical strain and usually detects pathologies when they have progressed so far that non-surgical interventions often don’t work. Using previous designs we demonstrated proof of concept for measuring screw bending with X-rays in Sawbones specimens, FEA models, cadaveric specimens, and tracked healing in a sheep. However, the old designs were cumbersome to insert and read, thus this Phase I proposal designs an elegant addon with a gain mechanism and readout on indicator along the pin. We will develop and test the design in FEA computational models, sawbones, and cadaveric specimens. The clinical, industry, and academic partners assembled for this work have a strong history of collaboration in orthopaedic device development and testing. They bring together expertise in measurement systems, mechanical testing, medical device design and orthopaedic surgery. The research is relevant to public health because, it provides a non-invasive means of assessing biomechanical reduction and postop fracture healing to avoid costly and risky revisions.

抽象的我们正在开发传感器 X-VISUAL（应用螺钉弯曲的 X 射线可视化指示器）负载），以跟踪用于治疗髋部骨折的空心螺钉的骨折愈合情况是主要的公众。约 330,000 例髋关节固定手术导致健康问题。在美国每年进行一次髋关节固定硬件的平均失败率约为 5%，但会增加到超过20%的患者患有骨质疏松症、不稳定骨折和初始骨折不良等合并症当愈合延迟时，螺钉、其他硬件和骨骼可能会疲劳并失效，从而需要昂贵的费用。对于这些虚弱的患者来说，翻修手术具有显着的发病率和死亡率风险。手术后 30 天内重新入院的患者的全因死亡率为 56%，而手术后 30 天内重新入院的患者的全因死亡率为 19% 螺钉仅在加载时弯曲和切断，并且这种风险随着骨折而消失。愈伤组织愈合并承受载荷因此，测量静力载荷下的螺钉弯曲度是测量螺钉弯曲的理想方法。评估骨折愈合和失败风险，这可以改善与患者和护理团队的沟通，使正常康复的患者和物理治疗师能够在活动中感到更舒适，同时创新地，X-VISUAL 是第一个传感器，用于检测和避免缓慢康复患者的病变。可以检测螺钉弯曲（以及螺钉上的相关负载），这种测量很难在由于几何形状有限，该受专利保护的装置设计用于加载到螺钉中。去除导丝后，使用医疗保健中普遍可用的普通放射线照相术读取设施，但通常对机械应变不敏感，并且通常在出现病变时检测到病变到目前为止，我们所展示的非手术干预措施通常不起作用。使用 X 射线在 Sawbones 样本、FEA 模型、尸体中测量螺钉弯曲的概念验证然而，旧的设计插入和读取起来很麻烦，因此，第一阶段提案设计了一个优雅的插件，带有增益机制和指示器读数我们将在 FEA 计算模型、锯骨和尸体中开发和测试设计。为这项工作聚集的临床、工业和学术合作伙伴有着悠久的历史。他们在骨科设备开发和测试方面进行合作，汇集了测量方面的专业知识。该研究与系统、机械测试、医疗设备设计和骨科手术相关。公共卫生，因为它提供了一种评估生物力学减少和术后的非侵入性方法骨折愈合以避免昂贵且有风险的修复。