Salt Lake Regional Medical Center, in conjunction with Active Implants, LLC, announced that the first meniscus replacement in the SUN (Safety Using NUsurface) clinical trial has been performed by Andrew Cooper, M.D. This 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. This trial is designed to assess the safety and effectiveness of the NUsurface Meniscus Implant in restoring function similar to that of a natural, healthy meniscus.
First Meniscus Replacement in SUN Trial Completed
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According to the May 19, 2016, news release, “The recipient of the implant was 55-year-old Uintah resident Kent Carlson, who has experienced meniscus-related problems since he was a child as a result of skiing injuries. He underwent a meniscectomy and has been getting cortisone shots, but the pain has persisted to the point where sitting for long periods or bearing weight are uncomfortable. Even low-impact exercises like swimming and cycling can cause his knee to swell.”
“There aren’t many options for patients like Kent, 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 inserted into the knee joint through a small incision and patients typically can go home soon after the operation. After surgery, they undergo a six-week rehabilitation program. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and in Israel since 2011.
The SUN study (Safety Using NUsurface) will enroll approximately 120 patients as part of the regulatory process to gain approval from the FDA to sell the device in the U.S.
Dr. Cooper told OTW, “The most interesting part of being an investigator in the SUN study is working with an international team of developers and researchers to bring this groundbreaking technology to the U.S. I have a high volume of patients who are very active and are in need of a new treatment option for persistent knee pain following meniscectomy. The NUsurface procedure itself is also very intriguing to learn.”
“Although the NUsurface is a totally new approach to a meniscus implant, orthopedic surgeons will be surprised to learn how technically similar the procedure is to other knee surgeries, ” Cooper said.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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