Ivan Delevic, President & CEO
Knee-related problems are more common now and increasing rapidly in volume. This surge is mostly attributed to an overall increase in critical risk factors, such as obesity and osteoarthritis. Although knee replacement surgery is recommended as the only option for many patients, studies show almost one-fifth of the people undergoing knee replacement are dissatisfied one year after surgery. Common reasons include patients experiencing lingering pain, having a reduced range of motion, and their knees generally feeling unnatural.
Dr. Martin Roche, Founder and Chief Medical Officer of OrthoSensor and highly experienced orthopedic surgeon, believes low patient satisfaction is related to a lack of proper soft tissue balancing during total knee replacements. The knee joint is held together by several ligaments, and the balancing of these soft tissues across the knee during surgery has historically been very subjective. Dr. Roche’s vision to improve patient outcomes and recovery time by quantifying this balance data during surgery led to the genesis of VERASENSE. VERASENSE is the first product from OrthoSensor, Inc. and the first step in the quest to use sensors to quantify orthopedic health data.
VERASENSE—a single-use, wireless, disposable device— uses microelectronic sensors to measure soft tissue loads in medial and lateral compartments of the knee during surgery. This data is wirelessly transmitted to a display in the operating room as the knee is moved through the range of motions. This helps surgeons balance the knee by quantifying what was previously judged by hand through subjective feel.
A randomized clinical trial proved that feel-based balancing of the knee, regardless of surgeon experience, has a wide bell curve. One highly trained surgeon tested this hypothesis by recording VERASENSE load readings after subjectively balancing the knee himself. He found he hit the mark only about 60 percent of the time by hand but was able to greatly increase this by using VERASENSE data.
VERASENSE load data can be stored within OrthoLogIQ—a HIPAA-compliant, cloud-based, orthopaedic patient registry. OrthoLogIQ’s power comes from combining this intraoperative balance data with electronic medical record patient demographic information, a record of the implants used during surgery, and patient-reported outcome measures to examine complete patient treatment care.
Eventually, the expanding OrthoLogIQ data repository will help surgeons understand how to handle specific cases and aid in predicting appropriately balanced knee loads for patients with certain risk factors. OrthoSensor’s President and CEO, Ivan Delevic says, “The database allows us to create various quality-related and outcomes-related benchmarks for surgeons, hospitals, and regions and ascertain the validity of certain decisions.” As the next step, by quantifying and analyzing this data, “we can contribute to healthcare in the U.S. by moving the orthopedic field away from a historically pay-for-service healthcare model to a pay-for-quality and outcomes model,” says Devlic.
VERASENSE replicates the exact size and shape of the normal polyethylene trial inserted between metal components placed on the ends of tibia and femur bones during surgery. Since component shapes are specific to individual implant companies, VERASENSE is frequently marketed in collaboration with OrthoSensor’s corporate partners, including three of the largest orthopedic manufacturers: Smith & Nephew, Stryker, and Zimmer Biomet. VERASENSE is available domestically and internationally through US-FDA approval, CE mark, and additional country-specific approvals.
According to Delevic, OrthoSensor plans to produce similar intraoperative sensors for other joints—including shoulders, hips, and ankles—and eventually to embed sensors into actual implants to measure long-term patient outcomes. As a medical device company creating digital data, OrthoSensor believes that, in the near future, they will transform themselves from being a medical device company using sensors into a data services company using sensors.