The PFOA II study
Treatment of kneecap arthritis
Knee arthritis,
a common condition
Knee (osteo)arthritis is a common joint disorder that causes pain and limits mobility due to cartilage damage. To date, only the symptoms can be alleviated. Since arthritis can continue to worsen, an artificial knee joint is often the only solution.
Cartilage cannot repair itself well. That is why knee arthritis does not heal on its own. We are looking for ways to replace damaged cartilage with healthy tissue – so that patients can move again without pain or limitations.
The PFOA II study
From Nose to Knee
Why are we conducting the PFOA II study?
We want our patients with kneecap arthritis, also known as patellofemoral osteoarthritis (PFOA), to live a pain-free life again.
Our idea is this:
We can re-grow healthy cartilage tissue in the laboratory.
We have developed a procedure in which we take a small tissue sample from the nasal septum and use it to grow cartilage tissue in the laboratory.
We have already shown that the cultured tissue from the nasal cartilage can be inserted into the knee.
In a national and an international study in which five hospitals participated, we succeeded in removing damaged cartilage tissue in the knee and replacing it with healthy cartilage tissue.
We cultivated this cartilage tissue from the patients' own nasal cartilage cells. None of the 65 people treated had serious side effects and the majority benefited from the treatment. However, the patients in these studies did not suffer from arthritis or only from an early form of arthritis.
In another study, we were able to successfully treat 5 patients with kneecap arthritis using this procedure. We were able to achieve significant improvements in symptoms.
We need further scientific evidence to confirm that this method is effective.
We now want to test this new treatment for kneecap arthritis on more patients to show that it is more effective than currently available treatments.
What are the goals of the
PFOA II study?
We would like to investigate which treatment method helps patients experience less pain and other knee problems.
We proceed as follows:
1.
We will randomly divide patients with mild to moderate kneecap arthritis into two groups.
2.
Group 1 receives standard therapy: three injections of "autologous blood" (platelet-enriched plasma).
3.
People in group 2 will have a tissue sample taken from the nasal septum, from which healthy cartilage tissue will be grown in the laboratory.
4.
This cultured tissue is then surgically inserted into the knee where the patient's own cartilage is damaged or no longer present.
Who can participate in the PFOA II study?
People of age
from 18 to 65 years and BMI ≤ 35,...
...with mild to moderate
(grade 1-3)
kneecap arthritis,...
... with a moderate to severe cartilage defect (grade 3-4)
on the kneecap and/or the femoral bearing.