A telemedicine approach for monitoring fracture healing via direct electromagnetic coupling

通过直接电磁耦合监测骨折愈合的远程医疗方法

• 批准号: 10116288
• 负责人: Christian Puttlitz
• 金额: $ 11.9万
• 依托单位: COLORADO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10116288
• 关键词: Acute; Address; Animal Model; Animals; Clinic; Clinical; Clinical Data; Clinical Trials; Computer Simulation; Computer Systems; Computer software; Cost Savings; Couples; Coupling; Data; Data Analyses; Data Collection; Detection; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Diagnostic radiologic examination; Early Diagnosis; Electromagnetics; Environment; Fibula Fracture; Foundations; Fracture; Fracture Fixation; Fracture Healing; Frequencies; Goals; Home; Implant; Measurement; Measures; Mechanics; Medical; Minerals; Monitor; Operative Surgical Procedures; Outcome; Patient-Focused Outcomes; Patients; Pattern; Phase; Postoperative Period; Process; Reporting; Research; Safety; Schedule; Series; Signal Transduction; Site; System; Techniques; Telemedicine; Telemetry; Testing; Time; Tissues; Visit; Wireless Technology; Work; biomaterial compatibility; cohort; computerized data processing; conditioning; cost effective; data exchange; digital health; encryption; experimental study; follow-up; healing; implanted sensor; improved; limb fracture; novel; radio frequency; recruit; self testing; sensor; software development; standard of care; tibia; time interval; wireless fidelity; wireless network

Project Summary Diagnostic monitoring of bone fracture healing is critical for the detection of delayed union or non-union. However, the course of fracture healing is not easily diagnosed during the early healing phase (first 4 weeks post-operative), when the value of standard radiographic information is limited due to the paucity of mineralized tissue within the fracture site and when the administration of additional therapies (such as osteobiologics) could be implemented with greater efficacy. In order to address this critical need, we have developed a radio- frequency system in which an external antenna electromagnetically couples with an implanted biocompatible, microelectromechanical system (bioMEMS) sensor to measure loading at the fracture site, and we have conclusively shown using a large animal model that these data can be used to predict the fracture's healing cascade during the early healing phase. We have advanced this work to develop a non-invasive measurement system in which the external antenna couples directly with the implanted hardware (such as a fracture fixation plate) to measure deformations due to an applied load (“direct electromagnetic coupling”, DEC), eliminating the need for an implanted sensor. The DEC technique has been evaluated through computational simulations, ex vivo experiments, and exploratory patient tests, which have demonstrated the efficacy for monitoring changes in fracture stability over the course of healing in a clinical setting. Our large animal study demonstrated that these fracture stability measurement systems are most effective at predicting fracture healing outcomes by utilizing frequent (bi-weekly) data collection to track changes in the temporal loading profile. However, clinical data collection opportunities are limited by the standard patient follow-up schedule (typically once every four weeks). Therefore, we propose to build upon our existing patient testing system to develop a novel digital health DEC (dhDEC) device in which the patient can perform data collection at their home and transmit these data for analyses in order to predict fracture healing outcomes. The device will consist of a loading frame for applying bending magnitudes up to 8 Nm to the patient's fractured limb, electromagnetic sensing hardware with a smaller footprint, a small computing system, and encrypted data transmission over Wi-Fi, all contained within the device frame. We propose to test this system and the approach of at-home patient measurement in a cohort of 16 patients with diaphyseal tibia fractures. The ability of the dhDEC system to monitor the healing process and predict fracture healing outcomes will be evaluated and compared to standard radiographic evidence. Successful completion of this proposal will establish the feasibility of using a telemedicine approach to obtain measurements of fracture stability at frequent time intervals during the critical early healing time period. The proposed telemedicine system may provide a significant cost savings to the medical system while delivering a substantial improvement in fracture healing management, and, ultimately, patient outcomes.

项目摘要 骨折愈合的诊断监测对于检测延迟愈合或不愈合至关重要。 然而，骨折愈合的过程在早期愈合阶段（前4周）不容易诊断 术后），当标准放射学信息的价值由于缺乏矿化而受到限制时， 骨折部位内的组织，以及给予其他治疗（如骨生物制剂）时 可以更有效地实施。为了满足这一迫切需求，我们开发了一种无线电- 频率系统，其中外部天线与植入的生物相容性， 微机电系统（bioMEMS）传感器来测量骨折部位的载荷，我们有 使用大型动物模型得出结论，这些数据可用于预测骨折愈合 在早期愈合阶段的级联。我们已经推进了这项工作，以开发一种非侵入性的测量方法， 外部天线直接与植入硬件（例如骨折固定）耦合的系统 板），以测量由于施加的负载（“直接电磁耦合”，DEC），消除了 需要植入传感器。DEC技术已通过计算模拟，例如 体内实验和探索性患者试验，这些试验证明了监测变化的有效性 在临床愈合过程中的骨折稳定性。我们的大型动物研究表明， 这些骨折稳定性测量系统在预测骨折愈合结果方面最有效， 利用频繁（每两周一次）的数据收集来跟踪时间负载分布的变化。但临床 数据收集机会受到标准患者随访时间表的限制（通常每四个月一次 周）。因此，我们建议建立在我们现有的病人测试系统，以开发一种新的数字 健康DEC（dhDEC）设备，其中患者可以在其家中执行数据收集并将这些数据传输到 分析数据，以预测骨折愈合结果。该器械将包括一个装载架， 对患者的骨折肢体施加高达8 Nm的弯曲幅度，电磁传感硬件 占地面积更小，计算系统更小，通过Wi-Fi进行加密数据传输，所有这些都包含在 在设备框架内。我们建议测试这个系统和方法，在家里的病人测量， 16例胫骨骨干骨折患者的队列研究。dhDEC系统监测愈合的能力 将对过程和预测骨折愈合结局进行评价，并与标准X线片进行比较 证据成功完成这项建议将确立使用远程医疗办法的可行性 在关键的早期愈合时间内以频繁的时间间隔获得骨折稳定性的测量值 期所提出的远程医疗系统可以为医疗系统提供显著的成本节约，同时 提供骨折愈合管理的实质性改善，并最终改善患者的预后。