Phase II has signed an agreement with the George Mason University SciTech Campus to develop and commercialize an exciting new technology.
Statement of the Problem and Unmet Need
The demand for primary total knee replacement (TKR) and arthroplasty surgeries following injury or diseases such as osteoarthritis, is projected to grow by 673% to 3.48 million procedures annually. The demand for knee revisions is expected to double by 2015. A high percentage of patients recovering from TKR surgery experience life threatening complications such as infection, thromboembolism, or misalignment. Moreover, a high percentage of patients do not have an optimal outcome in terms of joint mobility and range of motion due to patient inactivity or lack of access to rehabilitative facilities or personnel. We propose to commercialize a product that directly addresses this urgent need. In contrast to existing technologies, we have developed a novel soft wearable, rehabilitative sleeve that fits over the knee. The non-invasive soft sleeve contains embedded electronic sensors which detect joint movement and abnormalities in physiologic function. The product would be administered to patients on their way home from knee surgery and will wirelessly monitor the health and joint activity of the patient.
Description and Nature of the Project
We propose to validate our rehabilitation system against scientifically accepted rehabilitation systems and begin patient testing with the finalized device. The medical device is a soft, tight-fitting knee sleeve with integrated sensors and circuits to allow for the measurement of a variety of knee movements and vitals, such as range of motion, temperature differentials, and heart rate. The system collects information and processes it to provide the user and medical professional with meaningful data regarding their joint health. The sleeve can be calibrated to learn standard exercises as well as dynamic range of motion movements for each specific patient in order to provide baselines which will in turn generate alerts or notifications when a measurement is dangerously outside of baseline. We have two aims for this proposal. For aim 1 we will validate the rehabilitation system against a) 3-dimensional video biomechanical analyses of human movement in a variety of activities including running and jumping, b) research grade treadmills to detect running and gait patters, c) surface muscle activity and force plate data software, and d) electrocardiogram measurements. Under aim 2, we will focus on patient testing of the rehabilitation device for individuals who have undergone total knee replacement surgeries in order to analyze our system’s ability to successfully identify post-operative complications and improve patient rehabilitative health. Our goal is to provide a product which can effectively measure a patient’s joint vitals and generate alerts to degrading knee health.
Scientific and Clinical Impact
The focus of the current proposal is to provide patients and orthopedic doctors with a tool that will reduce patient inactivity and decrease the chance of post-operative complications. Our working device is a comfortable elastic legging, containing embedded electronics, worn over the knee. It is designed to simultaneously measure and track joint range and frequency of motion, acceleration, step impact, joint health (temperature differential, muscle activity, swelling, embolism, signs of infection) and to transmit this information real- time wirelessly and longitudinally to the treating physician and the phone of the patient. After a series of simple exercises, the knee monitor is calibrated for the individual patient. The scientific impact is high because it has never been possible in the past to non-invasively, and wirelessly, measure a set of physiologic and health parameters associated with both joint function and joint health.
The current project is in collaboration between George Mason University, the company partner Phase II, and the School of Physical Therapy & Athletic Training at Old Dominion University.