Moximed has announced the treatment of the first subject in the multi-centre MOTION randomised controlled trial (RCT) assessing its MISHA knee system against non-surgical treatment in individuals with medial knee osteoarthritis (OA).
This prospective trial is designed to assess the benefits of the MISHA system compared with non-surgical treatment options endorsed by the American Academy of Orthopaedic Surgeons (AAOS) Clinical Practice Guidelines.
These include physical therapy, weight management, physical conditioning, intra-articular injections, assistive devices, and various medications.
At least 100 participants will be randomised in the trial, which is currently enrolling at approximately ten sites across the US.
Enrolment locations include RUSH University Medical Center, NYU Langone Health, and Scripps Health.
The primary endpoint of the study is the improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score.
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By GlobalDataIn 2023, the MISHA knee system secured marketing authorisation from the US Food and Drug Administration (FDA).
The system claims to have demonstrated superiority to high tibial osteotomy (HTO) in two years after the operation.
It is specifically designed for those who have not found relief from previous treatments and are either ineligible for or unwilling to undergo joint replacement surgery.
Knee OA is said to arise when the joint’s natural shock absorbers, the cartilage and meniscus, fail to cushion it, resulting in chronic pain and restricted activity.
Moximed noted that as the first implantable shock absorber for the knee, the MISHA system minimises the load on the joint while walking, potentially alleviating pain, preserving joint function, and delaying the need for replacement surgery.
The device is implanted on the medial knee and is engineered to move in harmony with the joint, decreasing 30% of the peak force exerted on the knee during walking.
Moximed CEO and president Christopher Gleason said: 鈥淜nee OA patients across the country are looking for an effective and less invasive treatment option without activity restrictions.
鈥淭he growing commercial adoption of the MISHA knee system reflects the confidence that physicians and patients have in this breakthrough treatment.鈥�
