Wearable technology to reduce risk of DVT and increase patient compliance

摘要 深静脉血栓是全关节置换术(TJR)最令人畏惧的并发症，超过30万例全髋关节置换术和 美国每年总共进行70万次膝关节置换术。目前对术后的建议 TJR术后DVT的预防包括抗凝药物和/或间歇性气动加压 (IPC)至少10-14天。大多数当前的IPC设备都是非移动的，这使得 对于TJR患者来说，术后活动能力尤其重要，既麻烦又耗时。vt.在.的基础上 出院后，大多数患者都会回家接受药物预防DVT。即使在家中或外出时 按规定进行压迫治疗(IPC或压缩长袜)，数据显示遵从率低至 10%-50%。恢复力(RF)已经产生了下一代机械DVT预防，具有移动 该装置没有管子和泵，在移动过程中保持在适当的位置，重量轻， 持续磨损，旨在提高符合推荐使用的要求。第二阶段的假设 使用RF1400 IPC将导致更好的合规性，支持早期移动性并导致 与标准护理相比，TJR术后的功能活动度显著提高。作为一种延续 成功完成第一阶段，RF建议进行多中心试验(N=300)，以实现以下目标：AIM 1：根据第一阶段SBIR的调查结果优化产品设计。作为第一阶段的结果的几个发现 研究导致了一种重新设计的设备，称为RF1400第二代。这些发现包括需要 适合现有医院工作流程的设备，一次性小腿套，全面优化的电池和 跟踪移动性的能力。目的2.进行预防深静脉血栓的随机比较研究 标准IPC(组1)或RF1400(组2)用于TJR术后300例患者。卡伦·朱利亚诺博士 东北大学将作为与研究地点相关的工作的总体PI。这项研究将 包括住院阶段和门诊阶段，患者在两个临床地点：塔夫茨医疗中心和 印第安纳大学医学院，每个站点招收150名患者(75名对照组/75名试验组)。目标 3.测量患者报告的舒适度、设备接受度和易用性的结果(PRO)。总目标 第二阶段的目的是证明遵守推荐的用法、术后活动度和易用性 使用RF1400比使用标准IPC(住院)或使用标准IPC预防DVT显著更高 护理标准(在家)，为第三阶段期间TJR市场的全面商业化做准备。 预计到2021年，DVT治疗市场将达到38亿美元，美国占全球市场的50%以上。 鉴于目前抗凝剂DVT预防出血的风险为5.6%，这一技术的商业影响 研究表明，改善患者对RF1400深静脉血栓预防的依从性将改善术后 并为抗凝提供了一种有效的替代品。

Abstract DVT is the most feared complication of total joint replacement (TJR), with more than 300,000 total hip and 700,000 total knee replacements performed annually in the U.S. Current recommendations for postoperative DVT prophylaxis after TJR include anti-coagulant medications and/or intermittent pneumatic compression (IPC) of the lower limb for a minimum of 10-14 days. Most current IPC devices are non-mobile, making early postoperative mobility, which is especially important in TJR patients, cumbersome and time-consuming. Upon hospital discharge, most patients go home on pharmacologic DVT prophylaxis. Even when at-home external compression therapy is prescribed (IPC or compression stockings), data suggests compliance rates as low as 10-50%. Recovery Force (RF) has produced the next generation of mechanical DVT prophylaxis, with a mobile device absent of tubes and pumps, stays in place during ambulation, is lightweight and comfortable for continuous wear, and is designed to improve compliance with recommended use. The hypothesis for Phase II is that IPC using the RF1400 will result in improved compliance, support early mobility and result in significantly higher functional mobility after TJR as compared to standard of care. As a continuation of the successful completion of Phase I, RF proposes a multi-center trial (N=300) to achieve the following Aims: Aim 1: Optimize the product design based on findings from Phase I SBIR. Several findings as a result of Phase I study have led to a redesigned device, referred to as RF1400 Gen II. These findings include the need for the device to fit in the existing hospital work flows, for calf sleeves to be disposable, a fully optimized battery and the ability to track mobility. Aim 2. Conduct a randomized comparative study of DVT prophylaxis using either standard IPC (Group 1) or the RF1400 (Group 2) in 300 patients after TJR surgery. Dr. Karen Giuliano of Northeastern University will serve as the overall PI for efforts associated with the study sites. This study will include an inpatient phase and an outpatient phase with patients at two clinical sites: Tufts Medical Center and Indiana University School of Medicine, with each site enrolling 150 patients (75 control/75 experimental). Aim 3. Measure patient reported outcomes (PRO) of comfort, device acceptance and ease-of-use. The overall goal of Phase II is to demonstrate that compliance with recommended use, postoperative mobility, and ease-of-use is significantly higher with the RF1400 than with DVT prophylaxis using either standard IPC (in-hospital) or standard-of-care (at-home) in preparation for full commercialization in the TJR market during Phase III. The DVT therapy market is expected to hit $3.8B by 2021, and the US accounts for over 50% of the global market. With the current risk of bleeding from anticoagulant DVT prophylaxis at 5.6%, the commercial impact of this research is that improved patient compliance with the RF1400 DVT prophylaxis will improve postoperative mobility and provide an effective alternative to anticoagulation.