Image-guided, robot-assisted reduction of joint dislocation in orthopaedic surgery

图像引导、机器人辅助减少骨科手术中的关节脱位

• 批准号: 10461174
• 负责人: Ali Uneri
• 金额: $ 66.2万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10461174
• 关键词: 3-Dimensional; Address; Affect; Algorithms; Anatomy; Ankle; Ankle Fracture; Area; Cadaver; Chronic; Clinical; Clinical Research; Clinical Trials; Contralateral; Degenerative polyarthritis; Devices; Dislocations; Distal; Dose; Ensure; Evaluation; Fellowship; Fibula Fracture; Fluoroscopy; Fracture; Image; Image Analysis; Image-Guided Surgery; Incidence; Injury; Joint Dislocation; Joints; Lead; Low Dose Radiation; Manuals; Mechanics; Methods; Modernization; Morbidity - disease rate; Morphology; Muscular Atrophy; Operative Surgical Procedures; Orthopedic Surgery; Orthopedics; Outcome; Pain; Patient-Focused Outcomes; Patients; Performance; Pilot Projects; Positioning Attribute; Preclinical Testing; Quality of life; Radiation; Radiation Dose Unit; Reporting; Research; Risk; Robot; Robotics; Roentgen Rays; Role; Side; Source; Specialist; Specimen; Surgeon; System; Systems Integration; Techniques; Technology; Three-Dimensional Image; Three-Dimensional Imaging; Training; Translating; Trauma; Uncertainty; Work; X-Ray Medical Imaging; arm; base; bone; cone-beam computed tomography; cost; design; disability; experience; eye hand coordination; fibula; first-in-human; functional disability; functional outcomes; high risk; image guided; image registration; improved; instrument; long bone; long-term rehabilitation; multidisciplinary; novel; operation; radiological imaging; repaired; research clinical testing; restoration; robot assistance; robot control; robotic system; safety and feasibility; sample fixation; shape analysis; skills; software development; standard of care; success; trauma surgery

PROJECT SUMMARY / ABSTRACT Surgical treatment of joint fractures and dislocations following orthopaedic trauma requires accurate reduction and fixation of the joint space to restore anatomical integrity. In ankle fractures with syndesmotic injuries, inaccuracies in proper realignment are associated with chronic functional impairment, mechanical instability, and increased risk of osteoarthritis. Despite the prevalent role of intraoperative x-ray imaging, uncertainties in spatial reckoning of 3D joint morphology and challenges in hand-eye coordination can result in malreduction rates of up to 39–52% for fellowship- trained orthopedic trauma specialists. This proposal presents a novel system that combines intraoperative imaging, using low-dose CBCT and 3D-2D image registration, with robotic manipulation of the bones to precisely restore joint integrity. The solution offers quantitative analysis of morphology from 3D and 2D intraoperative images and precisely guides a robotic instrument without the need for and the limitations associated with conventional tracked navigation. The following aims develop and evaluate the approach for treatment of syndesmotic injuries in ankle trauma surgery: (Aim 1) Develop a surgical robot for joint reduction. (1a) Design a novel low-profile, radiolucent robotic system to manipulate the distal fibula. (1b) Build the device and develop software to control the robot position and orientation. (1c) Evaluate basic operation in preclinical testing on cadaveric ankle specimens. (Aim 2) Develop image-based planning and confirmation of joint reduction. (2a) Develop automatic 3D image analysis of the tibio-fibulo-talar space from low-dose CBCT and match the dislocated joint to the normal contralateral side. (2b) Develop 3D-2D image registration techniques to register the robot and confirm accurate restoration of the joint space from as few as 2 fluoroscopic views. (2c) Experimentally validate the algorithms on cadaveric ankle specimens. (Aim 3) Perform system integration and end-to-end evaluation of performance. (3a) Integrate the methods from Aims 1 and 2 to guide and confirm robotic manipulation from intraoperative images. (3b) Evaluate the system in cadaver specimens emulating ankle trauma, targeting less than 2 mm and 5° error in joint realignment. (Aim 4) Conduct clinical evaluation of safety and feasibility. Conduct clinical studies to (4a) observe standard of care of ankle fracture surgery and (4b) assess the basic safety and feasibility of the image-based robotic approach in a first in- human clinical trial with 10 patients. Successful completion of the aims will elevate the precision and quality of surgery in an area that currently suffers poor long-term outcomes through use of new methods that are consistent with existing workflows. Success in this research will help to eliminate revision surgeries due to malreduction (a major cost burden) and improve long-term quality of life for >100,000 patients/year. The platform will be developed in a multi-disciplinary consortium of experts in robotics, imaging, and orthopedic surgery and translated to clinical studies. The technology developed will impact trauma surgery beyond ankle repair and would be applicable to surgical treatment of other challenging joint dislocations and long-bone fractures.

项目概要/摘要 骨科创伤后关节骨折脱位的手术治疗需要准确复位和 固定关节间隙以恢复解剖学完整性。在伴有韧带联合损伤的踝关节骨折中， 适当的调整与慢性功能损伤、机械不稳定以及增加的风险有关 骨关节炎。尽管术中 X 射线成像发挥着普遍作用，但 3D 关节空间计算的不确定性 形态学和手眼协调方面的挑战可能导致奖学金的不良率高达 39-52%。 训练有素的创伤骨科专家。 该提案提出了一种结合术中成像、使用低剂量 CBCT 和 3D-2D 图像的新颖系统 注册，通过机器人操纵骨骼来精确恢复关节完整性。该解决方案提供定量 从 3D 和 2D 术中图像中分析形态并精确引导机器人器械，无需 以及与传统跟踪导航相关的局限性。以下目标是制定和评估 踝关节创伤手术中韧带联合损伤的治疗方法： （目标1）开发用于关节复位的手术机器人。 (1a) 设计一种新颖的低轮廓、射线可透过的机器人系统 操纵远端腓骨。 (1b) 构建设备并开发软件来控制机器人的位置和方向。 (1c) 评估尸体脚踝标本临床前测试的基本操作。 （目标2）制定基于图像的联合削减规划和确认。 (2a) 开发自动 3D 图像分析 低剂量 CBCT 的胫骨-腓骨-距骨间隙，并将脱位关节与正常对侧相匹配。 (2b) 开发 3D-2D 图像配准技术来配准机器人并确认关节空间的准确恢复 只需 2 个透视视图即可获得。 (2c) 在尸体脚踝标本上实验验证算法。 （目标 3）执行系统集成和端到端性能评估。 (3a) 整合目标 1 中的方法 2 根据术中图像指导和确认机器人操作。 (3b) 评估尸体系统 模拟踝关节创伤的标本，目标是关节重新对准时误差小于 2 毫米和 5°。 （目标4）进行安全性和可行性的临床评价。进行临床研究以 (4a) 观察患者的护理标准 踝关节骨折手术和（4b）首次评估基于图像的机器人方法的基本安全性和可行性 有 10 名患者参加的人体临床试验。 成功完成这些目标将提高目前贫困地区的手术精度和质量 通过使用与现有工作流程一致的新方法来实现长期成果。这项研究的成功将 有助于消除因复位不良而进行的翻修手术（主要的成本负担），并改善患者的长期生活质量 >100,000 名患者/年。该平台将由机器人、成像、 和骨科手术并转化为临床研究。所开发的技术将影响创伤手术 踝关节修复，并将适用于其他具有挑战性的关节脱位和长骨骨折的手术治疗。