Moximed launches new trial comparing implantable knee device to non-surgical OA treatments

Moximed launches trial of implantable knee-device: ©SasinParaksa - stock.adobe.com

Moximed has treated the first patients in a new randomized controlled trial evaluating its MISHA Knee System, the company announced this week. The trial, known as the MOTION RCT, will compare outcomes for patients with medial knee osteoarthritis (OA) who receive the implantable device versus those undergoing non-surgical treatment.

The prospective, multicenter study will enroll more than 100 patients across approximately 10 U.S. sites. Participating centers include NYU Langone Health, RUSH University Medical Center, The Ohio State University Wexner Medical Center, and Scripps Health. The trial’s primary endpoint is pain improvement measured by the WOMAC scale.

The MISHA Knee System, which received FDA clearance in 2023, is an implantable shock absorber designed to reduce joint load and preserve mobility for people who are not candidates for, or are unwilling to undergo, total knee replacement. The device works by unloading approximately 30% of the peak force on the knee during walking.

“Our participation in the MOTION RCT and the successful completion of our first case underscores our commitment to evaluating and adopting cutting-edge technologies,” said Adam Yanke, associate professor in the Department of Orthopedics at Midwest Orthopaedics at RUSH. “We believe the MISHA Knee System offers a significant step forward for patients seeking relief from knee osteoarthritis and a return to a more active life.”

The trial's control arm will include non-surgical treatments supported by the American Academy of Orthopaedic Surgeons, such as physical therapy, assistive devices, weight loss, medications, and injections.

Moximed says the study builds on a growing body of evidence for the MISHA Knee System. Five-year data from its pivotal FDA trial is expected by the end of 2025.

“To add to its clinical study arsenal, Moximed is now enrolling in this new RCT in addition to its ongoing post-market study,” said Brian Cole, acting chair and professor at Midwest Orthopaedics at RUSH. “These studies combined with the previous seven clinical studies make it clear that Moximed has taken a leadership position in generating high quality clinical evidence in support of an implantable shock absorber.”

Moximed CEO Christopher Gleason said demand for alternatives to total knee replacement is rising as patients seek effective, less invasive options that don’t limit activity. “The growing commercial adoption of the MISHA Knee System reflects the confidence that physicians and patients have in this breakthrough treatment,” he said.