Charles Sternberg, Associate Editor05.31.23
Two new peer-reviewed publications have reported additional supporting data for Moximed’s MISHA Knee System, an implantable shock absorber (ISA) for patients with osteoarthritis (OA) who are not ready for a knee replacement.
For patients suffering with knee OA but not ready for a knee replacement, the potential to delay arthroplasty is a significant attraction. Data from three clinical studies show that implantation of the ISA in symptomatic patients with knee OA resulted in a five-year freedom from arthroplasty rate of 85%. The results from the most recent study, which featured the commercially available MISHA Knee System and most advanced surgical instruments, showed the greatest survival rate, with a median three-year rate of over 97%.1
“For a highly symptomatic patient population that has exhausted conservative care and is not ready for joint replacement, there are limited patient-friendly surgical options,” stated Dennis Crawford, MD, PhD, Professor of Orthopedics and Rehabilitation, School of Medicine, Oregon Health and Science University, Portland. “The MISHA Knee System represents a new surgical service line, and the data support the tremendous pain relief and the potential to delay joint replacement for a meaningful time period.”
Simultaneously, a cohort of patients from the Calypso Study of the MISHA Knee System with subchondral insufficiency fractures of the knee (SIFK) demonstrated a reduced risk of conversion to arthroplasty when treated with the ISA compared to a matched cohort of non-surgically treated patients. This analysis, stratified patients for arthroplasty risk using the SIFK Score, a validated clinical tool developed by researchers at the Mayo Clinic. 2,3 Patients with high-risk SIFK scores are a clearly-defined population at greatly increased risk of near-term arthroplasty when treated with only non-surgical care.
At one year, patients with high-risk SIFK Scores were 100% free from arthroplasty in the ISA group compared with 33% free from conversion in the non-surgical treatment group.
At two years, patients with high-risk SIFK Scores were 100% free from conversion to arthroplasty in the ISA group compared with 0% free from conversion in the non-surgical treatment group.
The senior author of the paper, Aaron J. Krych, MD, Professor of Orthopedic Surgery and Co-chair of Sports Medicine at the Mayo Clinic, noted, “Orthopedic clinical research has defined the relationship between SIFK, joint load management, and risk of rapid progression to arthroplasty. We developed and validated the SIFK Score as an easily administered, clinic-based tool to help in shared decision-making with patients. Our analysis demonstrated that in the high-risk SIFK population, many of whom have meniscal root tears, the ISA is strongly associated with avoidance of arthroplasty at two years.”
For patients suffering with knee OA but not ready for a knee replacement, the potential to delay arthroplasty is a significant attraction. Data from three clinical studies show that implantation of the ISA in symptomatic patients with knee OA resulted in a five-year freedom from arthroplasty rate of 85%. The results from the most recent study, which featured the commercially available MISHA Knee System and most advanced surgical instruments, showed the greatest survival rate, with a median three-year rate of over 97%.1
“For a highly symptomatic patient population that has exhausted conservative care and is not ready for joint replacement, there are limited patient-friendly surgical options,” stated Dennis Crawford, MD, PhD, Professor of Orthopedics and Rehabilitation, School of Medicine, Oregon Health and Science University, Portland. “The MISHA Knee System represents a new surgical service line, and the data support the tremendous pain relief and the potential to delay joint replacement for a meaningful time period.”
Simultaneously, a cohort of patients from the Calypso Study of the MISHA Knee System with subchondral insufficiency fractures of the knee (SIFK) demonstrated a reduced risk of conversion to arthroplasty when treated with the ISA compared to a matched cohort of non-surgically treated patients. This analysis, stratified patients for arthroplasty risk using the SIFK Score, a validated clinical tool developed by researchers at the Mayo Clinic. 2,3 Patients with high-risk SIFK scores are a clearly-defined population at greatly increased risk of near-term arthroplasty when treated with only non-surgical care.
At one year, patients with high-risk SIFK Scores were 100% free from arthroplasty in the ISA group compared with 33% free from conversion in the non-surgical treatment group.
At two years, patients with high-risk SIFK Scores were 100% free from conversion to arthroplasty in the ISA group compared with 0% free from conversion in the non-surgical treatment group.
The senior author of the paper, Aaron J. Krych, MD, Professor of Orthopedic Surgery and Co-chair of Sports Medicine at the Mayo Clinic, noted, “Orthopedic clinical research has defined the relationship between SIFK, joint load management, and risk of rapid progression to arthroplasty. We developed and validated the SIFK Score as an easily administered, clinic-based tool to help in shared decision-making with patients. Our analysis demonstrated that in the high-risk SIFK population, many of whom have meniscal root tears, the ISA is strongly associated with avoidance of arthroplasty at two years.”