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Local Medical Center One of 10 Sites Nationwide Enrolling Patients in New Study of Investigational Meniscus Replacement

 

DURHAM, N.C.–(BUSINESS WIRE)–Active Implants, a company that develops orthopedic implant solutions, today announced that the company’s VENUS (Verification of the Effectiveness of the NUsurface® System) trial is now underway at Duke University Medical Center. Duke is the only center in the state – and just one of 10 sites nationwide – participating in the VENUS clinical trial to evaluate the company’s investigational meniscus implant 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.

“There are limited options for patients who experience persistent knee pain following meniscus surgery,” said William E. Garrett Jr., M.D., Ph.D., professor of Orthopaedic Surgery at Duke University School of Medicine. “Damage to the meniscus with loss of meniscal function can lead to activity-related pain in the near-term and, in some cases, to arthritis in the long-term.”

The VENUS study will enroll approximately 130 patients at orthopedic centers in the U.S., Europe and Israel. Participants who meet study requirements and agree to enter the trial are randomized to receive either the NUsurface device or non-surgical treatment, which is the current standard of care for patients with persistent knee pain following meniscus surgery. 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 study, call (844) 680-8951 or visit www.meniscus-trial.com.

About the NUsurface® Meniscus Implant

In the U.S., the NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. NUsurface 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 tissue. The NUsurface device mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is inserted into the knee joint through a small incision, and patients typically can go home soon after the operation. After surgery, patients undergo a six-week rehabilitation program. NUsurface has been used clinically in Europe since 2008 and Israel since 2011.

CAUTION Investigational device. Limited by United States law to investigational use.