Grossmont Orthopaedic Medical Group Only Site in San Diego County Enrolling Patients in Study of Investigational Meniscus Replacement
SAN DIEGO–(BUSINESS WIRE)–Active Implants, a company that develops orthopedic implant solutions, today announced that the company’s SUN (Safety Using NUsurface®) trial is now underway in San Diego. Dr. Scott A. Hacker at Grossmont Orthopaedic Medical Group is the only physician in San Diego County – and the center is one of just 10 sites nationwide – participating in the SUN clinical trial to evaluate the investigational NUsurface Meniscus Implant (pronounced “new surface”) for the treatment of persistent knee pain caused by injured or deteriorating meniscus cartilage.
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.
“Current treatments for meniscus-related chronic knee pain do not address the underlying biology of the knee pain,” Dr. Hacker said. “Injections and medications do provide temporary relief for some patients but are just masking the symptoms. We hope this study finds that the NUsurface implant addresses the underlying problem and gets rid of the discomfort, allowing patients to return to the leisure and work activities that had been hindered by pain.”
The SUN study 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 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.