MU Orthopaedic Surgeon Begins FDA-Approved Study for Novel Knee-Cartilage Implant
New biological implant helps the body regenerate its own cartilage
Seth L. Sherman, MD, a sports medicine orthopaedic surgeon at University of Missouri Health Care’s Missouri Orthopaedic Institute (@muhealth), recently became one of the first American surgeons to enroll patients in a clinical research study aimed at earning FDA approval for a new knee-cartilage implant.
Agili-C™ (CartiHeal, Israel) is a new implant designed to help patients with knee-cartilage defects regenerate their own healthy cartilage. The implant has been shown to be safe and effective in a series of clinical trials previously conducted in Europe and Israel. Sherman is one of 15 primary investigators in the United States conducting the FDA-approved study, which is the final step before earning FDA approval for the implant.
“We are thrilled to be on the leading edge of orthopaedic sports medicine and joint preservation,” Sherman said. “In the U.S., there are limited options for off-the-shelf cartilage repair that can be performed during a single surgical procedure. Benefits of this technology include its relative low cost, ease of use, and strong basic science and clinical track record.”
Cartilage damage is a common knee problem that occurs in patients of all ages. It can happen as a result of an injury, like a blow to the knee, or due to wear and tear over time. In any case, it causes knee swelling, stiffness and pain that can reduce function and decrease quality of life.
The Agili-C™ implant is a cell-free implant made of the inorganic exoskeleton of sea coral. The implant can be used in this study to treat a variety of cartilage defects and patient types, which is another reason it is attractive to orthopaedic surgeons.
“Often in studies like this one, we can enroll only a very strict subset of young, active patients with a single, isolated cartilage defect,” said Sherman. “In reality, that’s not the type of patient we see every day. This implant is different because it’s medically indicated for a wide range of situations, including patients with multiple cartilage defects and even those with mild to moderate osteoarthritis. We can use it in patients who are in their 20s or in those who are in their 60s. This versatility allows us to find more patients who may benefit from this procedure.”
Those who qualify for the study are randomly assigned either one of the traditional surgical options or the new implant. So far, Sherman has enrolled four patients in the study. He plans to enroll at least 25 before submitting his research to the FDA.
The implant is manufactured by CartiHeal, a medical device company headquartered in Kfar Saba, Isreal and Closter, New Jersey. To date, more than 400 patients in Europe and Israel — where the device has already been approved — have received the new implant. The Agili-CTM implant is not available for sale in the United States. It is an investigational device limited for use in the device study.
To find out if you qualify for this study, visit the CartiHeal website.
About the Missouri Orthopaedic Institute
The Missouri Orthopaedic Institute is central Missouri’s largest freestanding orthopaedic center, as well as the region’s most comprehensive orthopaedic surgery center. The Institute’s expert orthopaedic surgeons, nurses, rehabilitation staff and other health professionals offer patients a full range of care in a single location. The Missouri Orthopaedic Institute houses approximately 400 staff, including 34 physicians who specialize in sports medicine, joint replacement, pediatrics, hip and knee, foot and ankle, shoulder, hand, spine, oncology and trauma care.
About University of Missouri Health Care
As part of the state’s premier academic medical center, University of Missouri Health Care offers a full spectrum of care, ranging from primary care to highly specialized, multidisciplinary treatment for patients with the most severe illnesses and injuries. Patients from each of Missouri’s 114 counties are served by approximately 6,000 physicians, nurses and health care professionals at MU Health Care. MU Health Care facilities include Ellis Fischel Cancer Center, the Missouri Orthopaedic Institute, the Missouri Psychiatric Center, University Hospital, and Women’s and Children’s Hospital in Columbia. Affiliates include Capital Region Medical Center in Jefferson City, Columbia Family Medical Group, Columbia Surgical Associates, Fulton Medical Center and Rusk Rehabilitation Center. MU Health Care is a founding member of the Health Network of Missouri and MPact Health. More than 50 MU Health Care outpatient clinics in central Missouri receive outpatient visits exceeding 500,000 annually.