Two new peer-reviewed studies which collected safety and efficacy data for a novel, implantable knee shock absorber—which has been shown to be an effective alternative to knee arthroplasty for patients diagnosed with osteoarthritis—have recently been published. Here are some of the details.
The first study, “An implantable shock absorber yields an 85% survival-from-arthroplasty rate through 5 years in working-age patients with medial compartment knee osteoarthritis,” was published in the March 23, 2023, edition of Knee Surgery, Sports Traumatology, Arthroscopy.
The second study, “Improved 2-Year Freedom from Arthroplasty in Patients with High-Risk SIFK Scores and Medial Knee Osteoarthritis Treated with an Implantable Shock Absorber versus Non-Operative Care,” appears in the June 2023 edition of Cartilage.
The implantable knee shock absorber, which is brand named MISHA Knee System and manufactured by Fremont, California-based Moximed, Inc.—is indicated for symptomatic patients with knee OA. The most recent study (June 2023 in Cartilage) reported that 97% of the patients receiving the implant still had the implant (did not opt for arthroplasty) after three years. Overall, from all studies, the MISHA knee system demonstrated a five-year freedom from arthroplasty rate of 85%.
“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, M.D., Ph.D., 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.”
From the Calypso Study of the MISHA Knee System researchers documented that patients with high-risk subchondral insufficiency fractures of the knee are more likely to seek knee arthroplasty unless they are offered an alternative intervention—specifically the MISHA knee shock absorber. The Calypso research team designed a study where matched groups of knee OA patients were offered non-surgical interventions or the knee shock absorber. Here is what they found.
- At one year:
- 0% of high-risk subchondral insufficiency fractures of the knee patients who’d been treated with the implantable shock absorber opted for knee arthroplasty.
- 77% of high-risk subchondral insufficiency fractures of the knee patients who’d been treated with non-surgical interventions opted for knee arthroplasty surgery.
- At two years:
- 0% of high-risk subchondral insufficiency fractures of the knee patients opted for arthroplasty surgery.
- 100% of high-risk subchondral insufficiency fractures of the knee patients treated with non-surgical interventions opted for knee arthroplasty surgery.
“Remarkable Turnaround”
“I have multiple patients from the early trials, who went from disabled to healthy and active,” said Dr. Crawford to OTW. “One stands out because she was initially too young for the study, but her disease and disability were so limiting it threatened her occupation and thus health insurance coverage. By exception, she was permitted to be enrolled in the trial.”
“The surgery not only facilitated a remarkable turnaround with her knee pain and capacity, but she was inspired by her experience to attend nursing school. She now relates how her capacity since, as a result of the MISHA procedure allowed her to routinely work as a nurse in an ICU, caring for COVID patient for 12+ hours a day.”
Discussing what led him to be involved in the study, Dr. Crawford told OTW, “Essentially two things. First was the recognition as a practicing physician/surgeon that many patients with a common disabling disease had no therapeutically effective options to treat a ubiquitous form of early osteoarthritis. Second was the sound nature of the fundamental bio-mechanical principals that are at the core nature of this breakthrough medical device.”
