Robot-Assisted Femoroplasty with Intraoperative Biomechanical Feedback

具有术中生物力学反馈的机器人辅助股骨成形术

• 批准号: 9560807
• 负责人: MEHRAN ARMAND
• 金额: $ 37.99万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9560807
• 关键词: Animals; Area; Beds; Biomechanics; Bone Density; Bone necrosis; Cadaver; Case Study; Clinical; Computer software; Contralateral; Defect; Deterioration; Development; Disease; Distal; Ensure; Feedback; Femur; Fracture; Generations; Goals; Hip Fractures; Hip region structure; Human; Image; Impairment; Individual; Injections; Lead; Mechanics; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Orthopedics; Osteoporosis; Osteoporotic; Outcome; Patients; Pelvis; Performance; Pilot Projects; Prevention; Procedures; Radial; Reporting; Research; Risk; Robot; Robotics; Safety; Series; Stress; Surgeon; System; Techniques; Technology; Testing; Time; Update; Visit; Work; X-Ray Computed Tomography; alternative treatment; base; bone; bone loss; bone strength; clinical practice; computerized; fall risk; falls; fracture risk; high risk; humerus; hydrodynamic model; improved; minimally invasive; mortality; novel strategies; older patient; osteoporosis with pathological fracture; osteoporotic bone; osteosarcoma; prophylactic; robot assistance; tool

Project Summary There is a wealth of research on the extent to which bone loss may impair strength and increase the risk of fracture. The rate of mortality after hip fracture in elderly patients with osteoporosis is reported to be as high as 30%. It is suggested that augmentation of the femur is an effective countermeasure to reduce the risk of fracture in highly osteoporotic hips. This technique would be especially valuable for those patients at high risk of falls and the highest risk of mortality and morbidity if they were to sustain a fall. The few clinical case studies that have been performed on augmentation of the femur, suggest that a successful outcome requires detailed planning, biomechanical analysis, and precise control of the augmentation procedure to avoid generation of areas of high stress due to augmentation. Our long term goal is to develop a technology that enables the surgeon to precisely determine the extent of osteoporosis and fracture risk level, obtain an optimized surgical plan based on computerized mechanical analysis, perform a rapid and minimally invasive hip augmentation with intraoperative biomechanical feedback, and finally verify the outcome in one patient visit. In this project, we will develop a surgical test bed for proximal femur augmentation and demonstrate its feasibility. Towards this goal, we propose three aims: 1. Surgical planning workstation: based on our prior study we propose to develop a biomechanical planning module for patient-specific optimization of the bone augmentation procedure using preoperative CT scans. We propose to leverage our preliminary results and develop an integrated patient-specific model involving mechanical and hydrodynamic simulation of the bone strength due to the injection of the augmenting material that is suitable for the ubiquitous problem of predicting intraoperative cement injection. The planning workstation will also assess the fracture risk preoperatively as well as provide real-time updates of the predicted cement distribution and stress- state within the bone during the surgery. 2. Integrated surgical execution system: The workstation will provide key capabilities related to image- based registration, intraoperative updates of cement distribution, and robotic tools to control injection. We will integrate software and hardware components; advance the biomechanical planning into a viable intraoperative technology, and tackle segmentation/registration challenges identified in our previous studies. These challenges are described in detail in the research plan. 3. Integrated System Performance: We will investigate the functional performance, reliability, and overall system accuracy of precisely controlled bone augmentation through a series of cadaver studies. The study will also include a series of destructive cadaver tests to verify the system ability to strengthen osteoporotic femora. We will also investigate the safety of the procedure by performing a series of live large animal studies (n =4). The main purpose of large animal studies is demonstrating the safety of the procedure before performing human pilot studies. The technology developed in this project may lead to a highly needed alternative treatment that may be pivotal for patients at the risk of bone fracture due to osteoporosis.

项目摘要 有大量的研究表明，骨丢失可能会在多大程度上削弱力量并增加骨密度。 骨折的风险。据报道，老年骨质疏松症患者髋部骨折后的死亡率为 高达30%。提示股骨增大术是降低其危险性的有效对策 高度髋关节炎的骨折这项技术对那些高血压患者特别有价值。 福尔斯的风险，以及如果他们遭受跌倒，死亡和发病的最高风险。少数临床病例 对股骨增强进行的研究表明，成功的结果需要 详细的计划，生物力学分析和精确控制的增强程序，以避免 由于增大而产生高应力区域。 我们的长期目标是开发一种技术，使外科医生能够精确地确定 骨质疏松程度和骨折风险水平，根据计算机化的 力学分析，进行快速微创髋关节增强，术中 生物力学反馈，并最终在一次患者访视中验证结果。在这个项目中，我们将开发一个 股骨近端增强手术试验台，并证明其可行性。为了这个目标，我们 提出三个目标： 1.手术计划工作站：基于我们先前的研究，我们建议开发一种生物力学 规划模块，其用于使用以下各项对骨增量程序进行患者特定优化 术前CT扫描。我们建议利用我们的初步结果， 患者特定模型，涉及骨强度的机械和流体动力学模拟， 适用于普遍存在的预测问题的增强材料的注入 术中骨水泥注射。计划工作站还将评估骨折风险 以及提供预测骨水泥分布和应力的实时更新， 在手术过程中骨头内的状态。 2.集成手术执行系统：工作站将提供与图像相关的关键功能， 基于配准、骨水泥分布的术中更新和机器人工具，以控制 注射我们将整合软件和硬件组件;推进生物力学规划 成为一种可行的术中技术，并解决分割/配准的挑战， 我们以前的研究。研究计划中详细描述了这些挑战。 3.集成系统性能：我们将研究功能性能、可靠性和 通过一系列尸体精确控制骨增量的总体系统准确性 问题研究该研究还将包括一系列破坏性尸体测试，以验证系统的能力， 加强股骨干。我们还将通过执行一项 一系列活体大型动物研究（n =4）。大型动物研究的主要目的是证明 在进行人体试验研究之前，对程序的安全性进行评估。 该项目开发的技术可能会导致一种非常需要的替代治疗方法， 对于骨质疏松症导致骨折风险的患者至关重要。