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Home/Large Joints and Extremities/Plastic Meniscus Implant Faces Trial
Large Joints and Extremities

Plastic Meniscus Implant Faces Trial

November 18, 2015 2 min read Premium comments

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Plastic Meniscus Implant Faces Trial
Courtesy of Active Implants
Secondary

Lenox Hill Hospital in New York City is one of ten sites nationwide that are participating in a clinical trial of Active Implants LLC’s device, the VENUS implant for injured or deteriorating meniscus cartilage. The acronym VENUS stands for Verification of the Effectiveness of the NUsurface System.

Once damaged, the meniscus has a limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year. Unfortunately, many patients still experience knee pain following meniscus surgery. One million is approximately the same number of knee ad hip replacement surgeries that are performed annually in the U.S.

The Nusurface Implant is made from medical grade plastic and, according to Active Implants officials, 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. Following surgery, patients undergo a six-week rehabilitation program. NUsurface has been used clinically in Europe since 2008 and in Israel since 2012.

“There aren’t many options for patients who experience persistent knee pain following meniscus surgery, ” said Elliott Hershman, M.D., Chairman of Orthopaedic Surgery at Lenox Hill Hospital. “Damage to the meniscus can lead to arthritis and the need for knee replacement surgery. We hope this study finds that the NUsurface Implant alleviates pain in these patients, as well as helps them delay or avoid knee replacement surgery.”

The VENUS study will enroll approximately 130 patients at orthopedic centers in the U.S., Europe and Israel. Participants who meet study requirements will be 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.

Lenox Hill Hospital is a member of the North Shore-LIJ Health System, which is changing its name in January 2016 to Northwell Health. Lenox Hill is a 652-bed, fully accredited, acute care hospital located on Manhattan’s Upper East Side with a national reputation for outstanding patient care and innovative medical and surgical treatments.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

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?

8
JT
James Thornton, MDSpine Fellow · HSS

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.

5
RP
R. PatelSports Medicine · Stanford

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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