This is an archived article that was published on sltrib.com in 2016, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

A 55-year-old Uintah resident received a knee implant that may soon transform the way many Americans live. Kent Carlson, received the first meniscus replacement in the SUN (Safety Using NUsurface®) clinical trial, performed by Dr. Andrew Cooper at Salt Lake Regional Medical Center in May. Salt Lake Regional Medical Center is the only hospital in Utah – 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.

The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. More than 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.

Carlson was one of those patients who suffered from chronic knee pain. His meniscus issues began as a child after sustaining ski injuries. He had received cortisone shots for years after his original meniscectomy but sitting for long periods, bearing weight, or even low-impact exercises like swimming and cycling made his knee swell.

"There aren't many options for patients like Mr. Carlson, who experienced persistent knee pain following meniscus surgery," said Dr. Andrew Cooper, orthopedic surgeon at Salt Lake Regional Medical Center. "Damage to the meniscus can lead to arthritis and the need for knee replacement surgery. We hope the NUsurface implant alleviates pain in these patients, as well as helps them delay or avoid knee replacement surgery."

The NUsurface Meniscus Implant is being studied as a replacement for the knee joint's cartilage pad between the thigh and shin bones. 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, the implant could help more than one million Americans a year who have had meniscus surgery 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."

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 U.S. 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.

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.