SBIR-STTR Award

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.

Public Health Relevance Statement:


Public Health Relevance:
Hip and Knee replacement procedures will continue to increase dramatically over the next twenty years and the rate of revision surgery is expected to remain stable around 17-18%. This will increase the burden on orthopaedic surgeons, operating room capacity, and healthcare cost. In 2007 dollars, this volume of total joint replacement would generate costs exceeding $100 billion, or 1% of the gross domestic product (GDP). If successful, the new monitoring device object of this proposal named "Joint Health Monitor" will have an immediate impact on managing joint degradation, reducing complicated revision surgeries and allowing more effective patient surveillance avoiding catastrophic failure; this in turn will increase patient confidence in regulatory agencies and industry.

Project Terms:
Acoustics; adverse outcome; Algorithms; Architecture; Arithmetic; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Attention; attenuation; base; Biometry; Bone Tissue; Characteristics; Classification; Clinical; cohort; Consumer Advocacy; Controlled Environment; cost; Data; Degenerative polyarthritis; Dependence; design; Detection; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic radiologic examination; Dietary Supplements; Discrimination (Psychology); Dislocations; Early Diagnosis; Evaluation; Exercise; Failure (biologic function); Feedback; follow-up; Goals; Health; Health Care Costs; Hip region structure; human subject; Implant; In Vitro; in vitro testing; in vivo; Industry; innovation; Joints; Knee; Machine Learning; Manufacturer Name; Measures; Methodology; Methods; Modality; Monitor; monitoring device; Morbidity - disease rate; Mortality Vital Statistics; Names; Operating Rooms; Operative Surgical Procedures; Orthopedics; Osteolysis; Outcome; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Pilot Projects; Procedures; Prosthesis; public health relevance; Radiation; rapid detection; Reaction; Regimen; Replacement Arthroplasty; Risk; sample fixation; Severities; Signal Transduction; Surgeon; System; Techniques; Testing; Time; Tissues; tool; Translating; Treatment Efficacy; Trust; Visit; Work; X-Ray Computed Tomography

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.

Public Health Relevance Statement:
Project Narrative - Relevance to Public Health Knee replacement procedures will continue to increase dramatically over the next twenty years and the rate of revision surgery is expected to remain stable around 10%. This will increase the burden on orthopaedic surgeons, operating room capacity, and healthcare cost. In 2007 dollars, this volume of total joint replacement would generate costs exceeding $100 billion, or 1% of the gross domestic product (GDP). If successful, the new monitoring device object of this proposal named “OrthoSonos” will have an immediate impact on managing joint degradation, reducing complicated revision surgeries, allowing more effective patient and implant manufacturer surveillance avoiding catastrophic failure, and introduce an opportunity to improve therapeutics of problematic implants; this in turn will increase patient confidence in regulatory agencies and industry while improving patient outcomes.

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