By StoryStudio

A new knee implant may soon transform the way many Americans live.

The NUsurface Meniscus Implant, a replacement for the knee joint’s cartilage pad between the thigh and shin bones, has gone into a second clinical trial to assess its safety and effectiveness in functioning like a natural meniscus.

A healthy meniscus balances body weight across the knee, but if torn or injured, it causes pain, swelling, stiffness, limited mobility, joint instability, knee joint catching or popping, and may lead to arthritis and the need for a knee replacement. Treatment is extremely limited – typically a combination of ice, rest, and cortisone injections, and, as a last resort, surgery to remove all or part of the meniscus.

If the FDA approves the NUsurface, however, the implant could help over a million Americans a year who have had meniscus surgery (the same amount as the number of hip and knee replacements a year combined), yet suffer from pain so severe, even after surgery, that they’re unable to live a normal, active life.

“A damaged meniscus has a very limited healing potential, oftentimes leading to knee replacement surgery,” said Henry Klyce, CEO of Active Implants, a company that specializes in orthopedic implants and invented the NUsurface. “There is an unmet need in the orthopedic market for a treatment option – such as our investigational NUsurface Meniscus Implant – that can fill the gap between minimally invasive meniscus surgery and total knee replacement.”

Orthopedic surgeon Dr. Andrew Cooper performed the first surgery in the SUN (Safety Using NUsurface) study, the second clinical trial, was performed at Salt Lake Regional Medical Center in Utah last month. Patient Kent Carlson, 55, had experienced meniscus issues since sustaining some ski injuries as a kid. He underwent a meniscectomy and received cortisone shots for years, but his pain grew to the point where sitting for long periods, bearing weight, or even low-impact exercises like swimming and cycling made his knee swell.

“I love to hunt, fish, and hike. I can’t wait to put on a pack and get back out there,” said Carlson, an avid outdoorsman, from Uintah, Utah.

Patients go home soon after the operation, which only requires a small incision, and undergo a short six-week rehabilitation program afterward. Because of the implant’s composite structure and design, the piece, made of medical-grade plastic, doesn’t require fixation to bone or soft tissues and more closely mimics the function of the natural meniscus, which quickens the healing process.

The NUsurface has been used across Europe since 2008, in Israel since 2011, and is now in two clinical trials in the US. The VENUS trial (Verification of the Effectiveness of the NUsurface System) has been underway at 10 sites since January 2015; the SUN trial (Safety Using NUsurface) started in February and will enroll about 120 patients with injured or deteriorating meniscus cartilage at up to 20 sites nationwide.

“There aren’t many options for patients who experience persistent knee pain following meniscus surgery,” said Dr. William Montgomery at St. Mary’s Medical Center in San Francisco, one of the locations participating in the SUN clinical study. “We hope the NUsurface implant alleviates pain in these patients, helps them delay or avoid knee replacement surgery, and gets them back to the activities they love.”

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. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To learn more, please visit sun-trial.com or call (844) 680-8951.