February 09, 2017
ARLINGTON, Texas–(BUSINESS WIRE)–Arlington Orthopedic Associates, P.A., one of the largest orthopedic practices in North Texas, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedures in Texas were successfully performed by Dr. Joseph Berman. Arlington Orthopedic Associates and its affiliate Baylor Orthopedic and Spine Hospital is the only center in the state – and one of just 10 sites nationwide – enrolling patients with persistent knee pain caused by injured or deteriorating meniscus cartilage in the SUN trial, which is designed to assess the safety and effectiveness of the NUsurface® Meniscus Implant (pronounced “new surface”) in restoring function similar to that of a natural, healthy meniscus.
One of the recipients was 44-year-old Denton resident Jon Foerster, who tore his meniscus five years ago while running the bases during a kickball game. Although he underwent a partial meniscectomy to treat the tear, he continued to suffer from aching pain while running or playing sports. His pain persisted to the point where he had to discontinue all high impact activities, including the sports he loved like soccer, kickball and skiing. Gradually, Foerster found that even with a high pain tolerance level, his knee pain became so severe he found it taxing to walk more than one mile and also had trouble sleeping at night.
The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.
“There aren’t many options for patients like Jon who experience persistent knee pain following meniscus surgery,” said Dr. Joseph Berman, orthopedic surgeon at the Joint Preservation Center of Arlington Orthopedic Associates. “The NUsurface implant offers the hope of alleviating pain and swelling in these patients with chronic problems. We may well be able to help delay or even avoid knee replacement surgery, allowing these patients to get back to activities they love.”
Foerster received the NUsurface Meniscus Implant on January 16 through a small incision in his knee and he is now undergoing a six-week rehabilitation program. Foerster is looking forward to getting back into boating, skiing and spending time with his family once he recovers from the NUsurface surgery.
“Receiving the NUsurface Meniscus Implant will help me to look forward to my future with my kids,” Foerster said. “I want keep up as they continue to grow and be able to play sports with them.”
The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.
About the Clinical Trial
The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U.S. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.
About the NUsurface® Meniscus Implant
The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.
About Arlington Orthopedic Associates
Arlington Orthopedic Associates, P.A. is one of the largest orthopedic practices in North Texas providing orthopedic care to the Dallas and Fort Worth area. AOA has four offices in Arlington, Mansfield, Irving and Odessa. We specialize in sports medicine, orthopedic surgery, spine care, joint replacement and reconstruction, and the care of bones, ligaments, tendons, muscles and nerves in adults and children. Additional services include physical medicine and rehabilitation, as well as state-of-the-art imaging and diagnostics services, all at four suitable locations. For more information, visit www.arlingtonortho.com or call 817-375-5200.
About Active Implants
Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.
CAUTION Investigational device. Limited by United States law to investigational use.