Researchers Seeking Patients for Meniscus Clinical Study

ATRO Medical is seeking study participants to test a new procedure to place a meniscus prosthesis after the native one has been removed.

The study is being conducted at the orthopedic departments of Sint Maartenskliniek, the MUMC+ and Haaglanden Medical Center in The Netherlands. The researchers are investigating whether the reconstruction of the mensicus with this prosthesis improves pain relief and improvement of the knee mobility. They hope to enroll 10 patients.

The new TRAMMPOLIN meniscus prosthesis by ATRO Medical is made of medical grade plastic and provides shock absorbance as the knee bends and moves. The new implant will be placed via arthroscopy.

Eligibility criteria includes being between the ages of 18 and 70 and having a total or partially removed medial meniscus. After the implantation of the meniscus prosthesis the study participants will be monitored for two years.

Dr. Tony van Tienen said that the initial attempt at transplanting a meniscus prosthesis in 2019 did not go as planned. He said, “We saw too little function improvement with the first patients: The knee remained stiff after the implantation. Unfortunately, we had to remove a few meniscus prostheses.”

He added, “The good news is that we didn’t observe any further damages on the medial side of the knee. These patients have continued their usual care trajectory. But the initial complaints were still there. Therefore, the solution we would have liked to offer had not yet been realized.”

The Dutch Arthritis Society was one the first groups to initiate research on meniscus transplantation almost a decade ago. Most the preclinical research was conducted at the Radboud University Medical Center, where Dr. Van Tienen did much of the supervising.

Both he and Dr. Jan Hunik founded the startup ATRO Medical to bring the TRAMMPOLIN meniscus prostheses to market.

CEO Jan Hunik said, “As a startup, we have the opportunity to make a difference for many patients. In Europe, more than 400,000 patients with persistent knee pain after meniscus removal are waiting for a surgical solution that can reduce their pain. But first, we need to prove in small studies that the prostheses provides long-lasting pain relief. After the previous study, the design was changed and we have tested our meniscus prostheses even more extensively than before. The prostheses meet all the requirements. But actual function improvement it gives to a real patient will only become clear in practice.”

If you have patients interested in participating in the AIR2 study, they can find out more information at the ATRO Medical website or through the three participating clinics.