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: 10276975
• 负责人: Ali Uneri
• 金额: $ 68.75万
• 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/10276975
• 关键词: 3-Dimensional; Address; Affect; Algorithms; Anatomy; Ankle; Ankle Fracture; Area; Cadaver; Chronic; Clinical; Clinical Research; Clinical Trials; Contralateral; Degenerative polyarthritis; Devices; Diagnostic radiologic examination; 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; 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; 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.

项目摘要 /摘要 骨科创伤后关节骨折和脱位的手术治疗需要准确的减少和 关节空间的固定以恢复解剖完整性。在脚踝骨折中，造成联合损伤，不准确 适当的重新调整与慢性功能障碍，机械不稳定性以及增加的风险有关 骨关节炎。尽管术中X射线成像的角色很普遍，但在空间估算中的不确定性3D关节中的不确定性 奖学金的形态和手眼协调挑战可能导致laled染率高达39-52％。 训练有素的骨科创伤专家。 该提案提出了一种新的系统，该系统使用低剂量CBCT和3D-2D图像结合了术中成像 注册，通过机器人操纵骨骼以精确恢复关节完整性。该解决方案提供定量 分析3D和2D术中图像的形态，并精确地指导机器人仪器无需 与常规跟踪导航相关的限制。以下目标发展并评估 治疗踝关节损伤的方法： （AIM 1）开发一个手术机器人以减少关节。 （1a）设计一种新型的低调，射线可透明机器人系统 操纵远端腓骨。 （1B）构建设备和开发软件以控制机器人位置和方向。 （1C） 评估尸体踝关节样本上的临床前测试中的基本操作。 （目标2）制定基于图像的计划和关节减少的确认。 （2a）开发自动3D图像分析 从低剂量CBCT的胫骨纤维 - 塔拉尔空间与脱位关节与正常对侧侧相匹配。 （2b） 开发3D-2D图像注册技术来注册机器人并确认关节空间的准确恢复 从只有2个荧光镜观看。 （2C）实验验证尸体踝部标本上的算法。 （目标3）执行系统集成和端到端性能评估。 （3a）整合了目标1的方法 2指导和确认术中图像的机器人操纵。 （3B）评估尸体中的系统 模拟踝关节创伤的标本，靶向关节重新调整小于2 mm和5°误差。 （目标4）对安全性和可行性进行临床评估。对（4A）进行临床研究，观察 脚踝骨折手术和（4B）评估基于图像的机器人方法的基本安全性和可行性 人类临床试验有10例患者。 成功完成目标将提高目前遭受贫困地区的手术的精度和质量 长期结局通过使用与现有工作流程一致的新方法。这项研究的成功将 帮助消除由于er割而导致的修订手术（主要成本伯恩），并改善了长期生活质量 > 100,000名患者/年。该平台将在机器人技术，成像，，成像，成像专家联盟中开发 和骨科手术，转化为临床研究。开发的技术将影响创伤手术以外 踝关节修复，适用于其他挑战关节位错和长骨骨折的手术治疗。