Real-time Feedback for Post-Operative Rehabilitation of Rotator Cuff Repairs using Wireless Force-Sensing Suture Anchors

使用无线力感应缝合锚进行肩袖修复术后康复的实时反馈

• 批准号: 10251572
• 负责人: Salil Sidharthan Karipott
• 金额: $ 25.07万
• 依托单位: PENDERIA TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-07 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10251572
• 关键词: Affect; Animal Model; Articular Range of Motion; Biofeedback; Cadaver; Caring; Clinical; Cost Savings; Custom; Data Set; Detection; Development; Devices; Electronics; Ensure; Environment; Failure; Feedback; Funding; Goals; Health Care Costs; Health Insurance; Healthcare; Hospital Administrators; Human; Implant; Industry; Injury; Insurance; Intention; Interdisciplinary Study; Interview; Laboratories; Lead; Ligaments; Measurement; Measures; Mechanics; Medical; Medical Device; Medicine; Mission; Monitor; Nature; Operative Surgical Procedures; Orthopedics; Outcome; Pain; Patient-Focused Outcomes; Patients; Performance; Phase; Physical therapy; Physicians; Power Sources; Process; Protocols documentation; Provider; Recovery; Rehabilitation therapy; Research; Rogaine; Rotator Cuff; Shoulder; Site; Small Business Innovation Research Grant; Stress; Surgeon; Surgical sutures; Suture Techniques; System; Technical Expertise; Techniques; Technology; Tendon structure; Testing; Time; TimeLine; Translating; Wireless Technology; achilles tendon; base; biomaterial compatibility; clinical implementation; clinical practice; commercialization; computerized data processing; cost; design; detection platform; effectiveness evaluation; effectiveness study; evidence base; experience; experimental study; functional restoration; healing; high reward; high risk; improved; in vivo; mechanical force; monitoring device; physical therapist; portability; post-operative rehabilitation; pre-clinical; predictive modeling; preference; prevent; prototype; real time monitoring; reconstruction; regenerative rehabilitation; repaired; response; sensor; sensor technology; stress state; success; technology development; tissue regeneration; tissue repair; tool; treatment planning; treatment program; wearable device; wearable sensor technology

Abstract The emerging interdisciplinary research field of Regenerative Rehabilitation is based on recent evidence that post-operative rehabilitation is as important as surgical technique to achieve optimal functional restoration following orthopedic injuries. Despite this recognition, current rehabilitation protocols remain primarily based on qualitative prior experience or preferences and lack patient-specific, real-time quantitative feedback. The goal of this project is to develop a sensing system that can monitor the local mechanical environment at orthopedic repair sites, specifically rotator cuff surgeries, thus providing quantitative feedback for surgeons and physical therapists (PTs) to improve patient outcomes and reduce cost by optimizing rehabilitation time and reducing rates of failure and revision surgeries. The sensor would have other applications in large tendon reconstruction and rehabilitation such as Achilles tendon repair as well. The sensing system is based on battery-free sensors embedded in suture anchors used for rotator cuff repairs. The suture anchor is wirelessly monitored with a wearable device, allowing real-time, continuous biofeedback for surgeons and PTs to make informed decisions and accurately apply evidence-based care. To our knowledge, there is no comparable technology that can perform similar tasks efficiently, and successful implementation of our system could lead to significant cost savings in the orthopedic industry. We have performed preliminary experiments showing the technical feasibility, and conducted over 100 customer interviews confirming the need and market opportunity of this technology. We have also set up a funding strategy and collaborators for continuing study the effectiveness and commercialization of this technology. The goal of this Phase I project is to develop and evaluate the sensor system, as well as conduct an ex vivo experiment to demonstrate the functionality and practicality of the device- integrated sensor.

摘要 再生康复的新兴跨学科研究领域是基于最近的证据， 术后康复与手术技术同样重要，以实现最佳功能恢复 骨科受伤后。尽管认识到这一点，目前的康复方案仍然主要基于 定性的先前经验或偏好，并且缺乏患者特异性的实时定量反馈。的目标 本项目旨在开发一种能够监测骨科局部机械环境的传感系统。 修复部位，特别是肩袖手术，从而为外科医生和物理 治疗师（PT）通过优化康复时间和减少 失败率和翻修手术。该传感器在大型肌腱重建中还有其他应用 以及跟腱修复等康复治疗。传感系统基于无电池传感器 嵌入用于肩袖修复的缝线锚钉中。带线锚通过无线监测， 可穿戴设备，允许外科医生和PT进行实时、连续的生物反馈，以做出明智的决定 并准确地应用循证护理。据我们所知，没有可比的技术可以 有效地执行类似的任务，成功实施我们的系统可能会导致重大成本 骨科行业的储蓄。我们已经进行了初步的实验，显示了技术的可行性， 并进行了100多次客户访谈，确认了这项技术的需求和市场机会。我们 还制定了一项资助战略和合作伙伴，以继续研究 这项技术的商业化。第一阶段项目的目标是开发和评估传感器 系统，以及进行体外实验，以证明该设备的功能和实用性- 集成传感器