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.
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.
