Patients with persistent knee pain after meniscus removal can now participate in the AIR2 study at three locations in The Netherlands. This study aims on pain relief and improvement of the knee mobility through reconstruction of the meniscus. Only 10 patients participate in the new study into the new procedure under strict conditions.
Orthopaedic departments of the Sint Maartenskliniek, the MUMC+ and Haaglanden Medical Center are fully prepared despite of Covid-19. The new procedure for the placement of meniscus prosthesis has been extensively practiced. The new meniscus is placed at the site of native meniscus by the use of arthroscopy. The new TRAMMPOLIN® meniscus prosthesis is made of medical grade plastic and acts as a shock absorber in the affected knee. The accompanying surgical instruments are ready for their first clinical use.
As soon as a patient signs up, the orthopaedics department checks whether they meet an extensive number of criteria, such as medical history, weight, and age. In particular, adults from 18 till 70 years old who have had a total or partially removed medial meniscus. After implantation of the meniscus prosthesis, two years of periodic check-ups and examinations will follow.
The first application in humans of the meniscus prosthesis back in 2019 did not go entirely as planned. Orthopaedic Dr. Tony van Tienen explains: ‘’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. 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 realised.”
Replacing a meniscus isn’t as easy as it seems. This is proven by the fact that nearly a decade of research was needed prior to the first study. The Dutch Arthritis Society (ReumaNederland) was one of the first initiators of this research and still supports it. Most of the preclinical research was done at the Radboud University Medical Center, often under the supervision of Dr. van Tienen. He and Dr. Jan Hunik founded the startup ATRO Medical with the aim to bring the TRAMMPOLIN® meniscus prostheses to the patient.
CEO Jan Hunik speaks of a great opportunity and a great challenge. “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. Therefore, we’re looking for 10 people that are willing to participate in the AIR2 study.’’
Patients interested in participating in the AIR2 study can find more information on the ATRO Medical website or through the three participating clinics: The Sint Maartenskliniek, the MUMC+ and Haaglanden MC.