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: 9789005
• 负责人: Fabrizio Billi
• 金额: $ 57.9万
• 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 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9789005
• 关键词: Acoustics; Address; Affect; Age; Algorithms; Behavior; Biometry; Bone Tissue; Cadaver; Characteristics; Classification; Clinic; Controlled Environment; Data; Detection; Deterioration; Development; Devices; Diagnosis; Diagnostic; Diagnostic radiologic examination; Discrimination; Engineering; Ensure; Event; Failure; Family suidae; Frequencies; Generations; Geometry; Health Care Costs; Hip region structure; Human; Implant; In Vitro; Incidence; Industry; Intervention; Investigation; Joint Prosthesis; Joints; Knee; Knee Prosthesis; Knee joint; Knowledge; Lead; Ligaments; Location; Longevity; Manufacturer Name; Market Research; Methods; Modeling; Monitor; Morbidity - disease rate; Movement; Muscle; Names; Obesity; Operating Rooms; Operative Surgical Procedures; Orthopedics; Osteolysis; Outcome; Pain; Patient-Focused Outcomes; Patients; Phase; Postoperative Period; Procedures; Public Health; Reaction; Recommendation; Replacement Arthroplasty; Research; Risk; Second Look Surgery; Sensitivity and Specificity; Series; Severities; Signal Transduction; Skin; Source; Speed; Structure; Study Subject; Surgeon; System; Technology; Tendon structure; Testing; Therapeutic; Thick; Time; Tissues; Translating; Work; aging population; base; bone; bone loss; commercialization; cost; design; experience; fracture risk; human subject; improved; in vitro testing; joint destruction; knee replacement arthroplasty; meetings; monitoring device; mortality; pain relief; prevent; rapid detection; research clinical testing; research study; sensor; septic; sex; tool

Abstract The number of knee joint replacement procedures has increased exponentially over the last decade with no indications of slowing down. While sustaining highly successful outcomes, implant failures still occur and the annual incidence of knee revision surgeries remain steady around 10% of primary surgeries. Implant loosening has been cited as the dominant cause of long-term failure. Loosening, however, is only detectable when the bone loss is so great that gaps between the implant and the bone are visible in an x-ray image, by which time the loosening may be quite severe with an immediate risk of fracture of the remaining thickness of the bone around the implant. When a patient has pain in or around their knee implant, surgeons are generally reluctant to perform revision surgery in the absence of a clear diagnosis of the cause of the pain. A tool with high sensitivity and specificity and the ability to detect loosening better than current diagnostics would provide a surgeon with the ability to confirm, or rule out, loosening of the implant during the diagnostic assessment of a patient in pain. Bruin Biometrics LLC proposes to develop a non-invasive device that could detect loosening of an artificial knee implant with greater accuracy than the current diagnostics standard. The final product is envisioned as a strap-on device resembling a knee brace which uses sensors to capture acoustic emission and joint angle information while the test subject performs a series of flexion/extension movements. Multiple passive acoustic sensors are in contact with the skin to pick up naturally occurring acoustic emissions from within the body. Signals from the sensors are filtered, analyzed, and categorized to determine if any of the signals are caused by a loosened implant and the degree of loosening. During the related Phase-1 project, we verified a loose implant will produce distinctive acoustic events relative to well-functioning or otherwise worn implants. More recently, we established the additional uniqueness of these signals against naturally occurring native knee signals using a porcine knee model. Evidently, the characteristics of acoustic signals generated by native tissues, such as ligament, tendons, and muscles, are readily distinguishable from artificial joint signals through frequency domain feature filtering. The work proposed for the phase-2 research will build on this base knowledge and develop and optimize a diagnostic tool capable of capturing, locating, and classifying signals indicative of implant loosening. This work will start with further in vitro testing of knees and implant and progress through cadaveric tests and, finally, testing of the device in conjunction with clinical evaluation of live post-op human patients who are experiencing pain.

摘要 膝关节置换手术的数量在过去十年中呈指数级增长， 放缓的迹象。虽然维持了高度成功的结果，但植入失败仍然发生， 膝关节翻修手术的年发生率稳定在初次手术的10%左右。植入物松动 被认为是长期失败的主要原因。然而，只有当骨头 损失是如此之大，以致于在X射线图像中可以看到植入物和骨之间的间隙， 松动可能相当严重， 植入物当患者膝关节植入物内或周围疼痛时，外科医生通常不愿意 在没有明确诊断疼痛原因的情况下进行翻修手术。具有高灵敏度的工具 特异性和比当前诊断更好地检测松动的能力将为外科医生提供 在疼痛患者的诊断评估过程中确认或排除植入物松动的能力。 Bruin Biometrics LLC建议开发一种非侵入性设备，可以检测人工关节的松动。 膝关节植入物的准确性高于当前的诊断标准。最终产品预计 其使用传感器来捕获声发射和关节角度 当测试对象执行一系列屈曲/伸展运动时，多个被动声 传感器与皮肤接触以从体内拾取自然发生的声发射。 对来自传感器的信号进行过滤、分析和分类，以确定是否有任何信号是由 松动的植入物和松动的程度。在相关的第1阶段项目中，我们验证了松动的植入物 将产生相对于功能良好或以其他方式磨损的植入物的独特的声学事件。最近， 我们建立了额外的独特性，这些信号对自然发生的原生膝盖信号使用 猪膝关节模型。显然，由天然组织产生的声信号的特性，例如 韧带、肌腱和肌肉通过频率容易地与人造关节信号区分开 域特征过滤为第二阶段研究提出的工作将建立在这一基础知识的基础上， 开发和优化能够捕获、定位和分类指示植入物的信号的诊断工具 松动。这项工作将从膝关节和植入物的进一步体外测试开始，并通过尸体进行进展。 测试，最后，结合术后人类患者的临床评价对器械进行测试， 正在经历痛苦。