Rapid Detection of Common Failure Modes for Knee Prosthetics

快速检测膝关节假体的常见故障模式

• 批准号: 8906609
• 负责人: Fabrizio Billi
• 金额: $ 14.97万
• 依托单位: BRUIN BIOMETRICS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-01 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8906609
• 关键词: Acoustics; Algorithms; Architecture; Arithmetic; Attention; Biometry; Bone Tissue; Characteristics; Classification; Clinical; Consumer Advocacy; Controlled Environment; Data; Degenerative polyarthritis; Dependence; Detection; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic radiologic examination; Discrimination; Dislocations; Early Diagnosis; Evaluation; Exercise; Failure; Feedback; Goals; Health; Health Care Costs; Hip region structure; Implant; In Vitro; Industry; Joints; Knee; Knee Prosthesis; Machine Learning; Manufacturer Name; Measures; Methodology; Methods; Modality; Monitor; Morbidity - disease rate; Names; Operating Rooms; Operative Surgical Procedures; Orthopedics; Osteolysis; Outcome; Patient risk; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Pilot Projects; Procedures; Prosthesis; Radiation; Reaction; Regimen; Replacement Arthroplasty; Risk; Severities; Signal Transduction; Surgeon; System; Techniques; Testing; Time; Tissues; Translating; Treatment Efficacy; Trust; Visit; Work; X-Ray Computed Tomography; accurate diagnosis; adverse outcome; attenuation; base; cohort; cost; design; dietary supplements; follow-up; hip replacement arthroplasty; human subject; in vitro testing; in vivo; innovation; knee replacement arthroplasty; monitoring device; mortality; public health relevance; rapid detection; sample fixation; tool

 DESCRIPTION (provided by applicant): Bruin Biometrics' proposes to develop the Joint Health Monitor (JHM), an innovative low risk device capable of detecting artificial joint implant failure prior to all currently available diagnostic devices. Artificial joint replacements have demonstrated excellent clinical performance. However, failures do occur due to a multitude of factors including, aseptic loosening, wear, dislocation, osteolysis, and adverse local tissue reactions (ALTR), including pseudotumors and extensive tissue damage. Recent catastrophic failures associated with specific implant designs, and increasing concern over the severe clinical consequences of ALTR, have raised the attention of both consumer advocacy groups and regulatory agencies, in the US and abroad. It is evident that current diagnostic tools have failed to predict early enough complications associated with some implant designs and/or patient's characteristics. Rather than be predictive, current diagnostic methods usually do not detect joint degradation until bone and tissue damage have already occurred, increasing morbidity, mortality and severity of revision surgeries. Bruin Biometrics has developed an innovative monitoring device that will allow effective monitoring of an artificial joint functionality and eary detection of at risk patients, implant designs and reduction of the number or at least the severity of revision surgeries. Early detection should also enable physicians to prescribe exercise regimens, dietary supplements, medication, early revision surgery or other measures to protect against further damage. Moreover, the existence of an effective monitoring device would provide invaluable feedback, enabling unprecedented quantification and evaluation of treatment efficacy including drugs. The objectives of this proposal are to demonstrate the technical feasibility of this device to detect specific failure modes. This will be accomplished using an in vitro test rig set up and an in vivo human subject pilot study. Our overall goal is to rapidly delier a wearable system capable of monitoring the status of artificial joints and provide surgeons with more accurate and earlier diagnoses.

 描述（由申请人提供）：Bruin Biometrics 提议开发关节健康监测器（JHM），这是一种创新的低风险设备，能够在所有当前可用的诊断设备之前检测人工关节植入物的故障。人工关节置换术已表现出优异的临床表现。然而，由于多种因素确实会导致失败，包括无菌性松动、磨损、脱位、骨质溶解和不良局部组织反应 (ALTR)，包括假瘤和广泛的组织损伤。最近与特定植入物设计相关的灾难性失败，以及对 ALTR 严重临床后果的日益关注，引起了美国和国外消费者权益团体和监管机构的关注。显然，当前的诊断工具未能足够早地预测与某些植入物设计和/或患者特征相关的并发症。当前的诊断方法不是预测性的，而是通常在骨和组织损伤已经发生之前才检测到关节退化，从而增加了翻修手术的发病率、死亡率和严重程度。 Bruin Biometrics 开发了一种创新的监测设备，可以有效监测人工关节功能，早期检测高危患者、植入物设计，并减少数量或至少减少严重程度 修复手术。早期发现还应该使医生能够制定锻炼方案、膳食补充剂、药物、早期修复手术或其他措施，以防止进一步的损害。此外，有效监测设备的存在将提供宝贵的反馈，从而能够对包括药物在内的治疗效果进行前所未有的量化和评估。该提案的目的是证明该设备检测特定故障模式的技术可行性。这将通过体外试验装置和体内人类受试者试点研究来完成。我们的总体目标是快速提供能够监测人工关节状态的可穿戴系统，并为外科医生提供更准确、更早的诊断。