Three basic attributes make a medical device “smart” or “intelligent.”
- The ability to sense its environment
- The ability to process the data it collects
- The ability to communicate that processed data to an external network.
Increasingly, manufacturers are embedding these capabilities into their devices.
A San-Francisco-based company, Roam Robotics, announced that it is sponsoring a clinical study with the San Francisco VA Health Care System and the Northern California Institute for Research and Education, to test its “smart” knee brace. The study investigators hope to test the ability of a novel smart brace to deliver pain relief and improved function for patients with knee osteoarthritis.
According to the manufacturer, the “smart knee orthosis is designed to provide relief from knee pain and intuitively support everyday mobility.” In an earlier study of its smart brace, the company reported that researchers found evidence that this “smart” brace could reduce pain an average of 46% for patients with knee osteoarthritis, with 67% of study participants exhibiting functional improvement.
The “smart” knee brace is brand named Ascend.
Dr. Alfred Kuo, Chief of Orthopedic Surgery at the San Francisco VA Health Care System explained the genesis of the study to OTW: “Veterans suffer from musculoskeletal conditions such as knee arthritis at higher rates than the general population. We don’t have great treatment options for many of these patients, especially ones who have moderate disease. The Ascend brace has the potential to substantially improve pain, stability, and function.”
According to the study sponsor, Roam Robotics, the brace “Is the first wearable robotic device to show usefulness in everyday life for people suffering from knee pain who want to regain independence and live more active lifestyles.”
Users, said the company, typically suffer from knee osteoarthritis pain and reduced function but for whom traditional pain medications or steroid injections are poor treatment options, passive braces don’t offer adequate pain relief and when the primary option is total knee arthroplasty surgery. Additionally, noted the company, many users are too young for a knee replacement and want to avoid the risk of a revision surgery in the future or, as is often the case, are poor candidates due to comorbidities or cannot afford the surgery.
Tim Swift, Ph.D., CEO and founder of the manufacturer of the brace, provided details of the product to OTW. The brace, he said, “Is registered as a class I device with the FDA, has been clinically shown to provide pain reduction and significant functional improvement for knee osteoarthritis patients.” The company is promoting its brace in the San Francisco area and is hoping, with the additional data provided by the new study, to expand its digital outreach nationwide.
The company, said Swift, “Plans to ship limited quantities of Ascend starting mid-2022 and is already seeing robust demand through pre-orders.”
