ATRO Medical obtains permission to start clinical study with knee meniscus prosthesis
10 December 2018, Nijmegen, The Netherlands – ATRO Medical BV has obtained permission from the Healthcare and Youth Inspection to implant the meniscal prosthesis Trammpolin® in eighteen patients. ATRO Medical BV does this together with Radboudumc, the Maastricht UMC+ and the Sint Maartenskliniek. This clinical study is used to determine whether Trammpolin® leads to less pain and a more resilient knee in patients.
In a healthy knee, the meniscus acts as a shock absorber. Without a well-functioning shock absorber, pain and movement restrictions often occur in the knee. There is currently no surgical treatment for this. Only when the knee is seriously worn the whole knee joint is replaced by a total knee replacement. The Trammpolin® polymer prosthesis only replaces the meniscus and thus restores the shock absorber function. This prosthesis is intended for patients who have undergone a meniscectomy in which the meniscus has been completely or partially removed. This allows the period up to a total knee replacement to be bridged. The clinical examination now being performed should show whether the meniscal prosthesis is safe and whether the pain in the knee will actually decrease.
Orthopaedic surgeon Sebastiaan van de Groes van het Radboudumc: “Because the development of the Trammpolin® meniscus prosthesis has taken place in the Radboudumc and the prosthesis is also placed here in the first patients, we can quickly solve any points of interest. This allows a quick, efficient and safe introduction of this new implant.
“At the outpatient clinic we regularly see patients with pain in their knees due to meniscal wear and tear,” says orthopedic surgeon Koen Defoort of the Sint Maartenskliniek. “By placing this meniscal prosthesis we expect to be able to offer an effective and safe treatment for this patient group.
Permission to test
Meniscal prosthesis research began in 2011 with a public-private partnership in the field of clinical, biomechanical and materials research with academic centres and companies including the Orthopedic Research Laboratory (ORL) of Radboudumc. This was the foundation for the development of the current Trammpolin® prosthesis. The starting point was a shock-absorbing material, in the form of the natural meniscus, which could withstand the forces in the knee joint and was resistant to wear and tear. The surgical procedure had to be relatively simple and could be performed in any orthopaedic clinic by means of a keyhole surgery. In order to develop a meniscus for patients based on the prototype developed, ATRO Medical BV was founded in 2016. For two years, the meniscal prosthesis was extensively tested for function and safety. Based on these test results, the Healthcare Inspection gave its approval mid-2018 to conduct clinical research on eighteen patients. The first patients will be treated at Radboudumc. If the results are good, patients will also follow in the spring of 2019 at the Sint Maartenskliniek (Nijmegen) and the Maastricht UMC+.
Major step forward
“The start of clinical research is a major step forward for patients with chronic knee pain for whom there is currently no effective treatment,” said Tony van Tienen, orthopedic surgeon responsible for implant development at ATRO Medical. “In current practice, after years of treatment with painkillers, injections and physiotherapy, it is often decided to replace the entire joint with a total knee replacement. Our meniscal prosthesis can change this with a simple, effective procedure. We expect that with our meniscal prosthesis we can postpone the placement of a total knee replacement for 10 years.
With good results from this clinical study, the meniscal prosthesis could be approved on the European market in 2022.
Important notice: Trammpolin® has not yet been approved for commercial purposes and may only be used in clinical trials.