Study results indicate that Moximed’s MISHA Knee System, an implantable shock absorber (ISA) for the knee, was superior to high tibial osteotomy (HTO) when evaluated against a two-year composite endpoint, demonstrating pain relief, functional improvement and a positive safety profile in patients with medial knee osteoarthritis.
Major findings from the study include:
- Outpatient Surgery and Early Recovery: 90.5% of U.S. patients were discharged in under 24 hours, and the overall study population returned to full weight-bearing without assist devices by an average 13 days.
- High Responder Rates: 95.8% of patients treated with an ISA reported clinically meaningful pain relief at two years.
- Substantial Improvement: At 24 months, patients reported an average of 76% reduction in pain and 74% improvement in function compared to baseline levels.
- Favorable Safety: 95% of ISA patients were free from an endpoint safety event, and 100% of ISA devices were free from mechanical failure.
David R. Diduch, MD, the A.F. Voshell Professor of Sports Medicine, Department of Sports Medicine, University of Virginia, said, “The results demonstrated that nearly all the patients who received the MISHA Knee System experienced clinically meaningful pain relief at two years, and the safety profile of the device and procedure were comparable to a well-established surgical control. I anticipate many surgeons and patients will be excited to learn about this technology.”
Source: Moximed
Study results indicate that Moximed's MISHA Knee System, an implantable shock absorber (ISA) for the knee, was superior to high tibial osteotomy (HTO) when evaluated against a two-year composite endpoint, demonstrating pain relief, functional improvement and a positive safety profile in patients with medial knee osteoarthritis.
Major findings...
Study results indicate that Moximed’s MISHA Knee System, an implantable shock absorber (ISA) for the knee, was superior to high tibial osteotomy (HTO) when evaluated against a two-year composite endpoint, demonstrating pain relief, functional improvement and a positive safety profile in patients with medial knee osteoarthritis.
Major findings from the study include:
- Outpatient Surgery and Early Recovery: 90.5% of U.S. patients were discharged in under 24 hours, and the overall study population returned to full weight-bearing without assist devices by an average 13 days.
- High Responder Rates: 95.8% of patients treated with an ISA reported clinically meaningful pain relief at two years.
- Substantial Improvement: At 24 months, patients reported an average of 76% reduction in pain and 74% improvement in function compared to baseline levels.
- Favorable Safety: 95% of ISA patients were free from an endpoint safety event, and 100% of ISA devices were free from mechanical failure.
David R. Diduch, MD, the A.F. Voshell Professor of Sports Medicine, Department of Sports Medicine, University of Virginia, said, “The results demonstrated that nearly all the patients who received the MISHA Knee System experienced clinically meaningful pain relief at two years, and the safety profile of the device and procedure were comparable to a well-established surgical control. I anticipate many surgeons and patients will be excited to learn about this technology.”
Source: Moximed
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.