FREMONT, Calif. — Moximed, a medical device company focused on advancing care for knee osteoarthritis, announced that the first patients have been treated in a new randomized controlled trial evaluating the MISHA® Knee System against non-surgical treatment options. The trial, known as the MOTION RCT, is being conducted across leading orthopedic institutions in the United States and marks a significant step in expanding the clinical evidence supporting surgical unloading as a treatment approach.
The study is enrolling over 100 participants with medial knee osteoarthritis, comparing outcomes between those who receive the MISHA Knee System and those undergoing guideline-supported non-surgical treatments. These non-surgical interventions include weight loss, physical therapy, assistive devices, joint injections, and medication, following recommendations from the American Academy of Orthopaedic Surgeons.
Prestigious institutions such as NYU Langone Health, RUSH University Medical Center, The Ohio State University Wexner Medical Center, and Scripps Health are actively enrolling patients. The trial’s primary focus is improvement in pain, measured by the WOMAC Pain Score.
Dr. Adam Yanke of Midwest Orthopaedics at RUSH praised the study’s significance, stating that the first case was completed successfully and reflects a growing commitment to exploring new technologies. He noted the potential of the MISHA Knee System to offer meaningful relief to patients with osteoarthritis who are seeking alternatives to more invasive surgeries.
Cleared by the FDA in 2023, the MISHA Knee System is already in commercial use and has demonstrated superior outcomes compared to high tibial osteotomy (HTO) at the two-year post-operative mark. Additional five-year data from the FDA’s pivotal trial is expected by the end of 2025.
Dr. Brian Cole, Acting Chair of Orthopedics at RUSH, highlighted Moximed’s leadership in clinical research, citing the company’s commitment to generating robust data through multiple ongoing studies, including this new RCT and a parallel post-market study. He emphasized the value of joint unloading as a long-standing, clinically validated approach to managing osteoarthritis and welcomed more data to support its broader adoption.
Christopher Gleason, President and CEO of Moximed, underscored the demand among patients for effective, minimally invasive solutions without activity restrictions. He said the growing adoption of the MISHA Knee System reflects the confidence both physicians and patients have in the device, and he expressed pride in partnering with top-tier orthopedic centers to further validate its benefits.
