Benefits and Risks

Voordelen en risico's osseointegratie

Is an osseointegration (click) prosthesis safe?

For patients with a leg amputation who experience problems wearing a socket prosthesis, there is now a new method for anchoring the prosthesis to the body. The surgeon can insert an orthopedic implant through the skin directly into the bone of the stump. The artificial leg can be connected to this implant by means of a click system. This new technique is called osseointegration, and the prosthesis is also called click prosthesis. Doctors use the term osseointegration prosthesis or bone anchoring prosthesis. The opening of the skin through which the implant protrudes is called a stoma.

What is the principle of osseointegration?

The osseointegration prosthesis comes from dentistry. In the 1960s, the Swedish scientist Brånemark discovered that bone adheres very well to the surface of a titanium screw. This connection of metal with bone is called osseointegration and this principle is now used by orthopedists to make hip and knee prostheses on a large scale in the bone. Since the 1990s, this osseointegration technique has been further developed for people with an arm or leg amputation. In contrast to a hip or knee prosthesis, the implant protrudes through the skin so that an artificial arm or leg can be clicked onto it. Since 2009, the osseointegration (click) prosthesis has also been used in the Netherlands and is currently experiencing spectacular growth.

Is an osseointegrated (click) prosthesis safe?

Yes, this is a safe treatment. Since 2009, surgeon Dr Jan Paul Frölke and rehabilitation physician Dr Henk van de Meent and their research team from Radboudumc Nijmegen have followed all patients treated with an osseointegration prosthesis in collaboration with other major centers in the world. They not only investigated the advantages of this treatment, but also mapped out the disadvantages and possible complications. Initially it was thought that the implant would lead to infection of the bone and loosening of the implant. Research published in American international scientific journals showed that the risk of loosening is very small in the first 84 patients with an osseointegration prosthesis. In 1 patient the implant became detached and had to be replaced. Follow-up studies confirmed this, but more than two-thirds of people were found to have regular stoma irritation and infections. Especially in people who smoke and in people with a high body weight. However, the stoma complaints were easy to treat and are often transient. Due to recently developed new surgical techniques, stoma problems are still rare and the complaints are less. We now see stoma complaints mainly in the first two years after surgery.

What are the advantages of an osseointegrated (click) prosthesis?

The advantages of the osseointegrated (click) prosthesis compared to the socket prosthesis appear to be significant after one year, but this improvement also continues after two and five years. From research among the first patients treated in the Netherlands, the prosthesis wear time increased considerably, the walking distance increased and walking also cost less energy. Quality of life improved and the X-ray examination of the bone showed that the stump bone was getting stronger and thicker. A major advantage of the osseointegration prosthesis is that the prosthesis is stably anchored to the bone. As a result, people feel more secure, can sit and cycle better and in the summer they do not suffer from perspiration. Another interesting advantage is that people with an osseointegration prosthesis can feel the substrate. The vibrations that occur when walking on a smooth or rough surface is detected in the bone via the implant. This phenomenon is called osseoperception (feeling with the bone) and gives the person with an osseointegrator prosthesis the feeling of having his or her own leg back.

What are the risks of an osseointegrated (click) prosthesis?

Since 2009 the medical specialists of AOFE clinics have followed all patients they have treated with an osseointegrator prosthesis. They have investigated the benefits and risks of an osseointegration prosthesis. Initially, it was thought that an implant protruding through the skin would lead to infection of the bone and detachment of the implant. This study of the first 84 patients with an osseointegration prosthesis showed that the risk is very small. In 2% the implant loosened from the bone and the implant had to be replaced. Stoma irritation and infections do occur, especially in people who smoke and people with a high body weight. The stoma complaints are easy to treat and are often transient. Due to recently developed new surgical techniques to create the stoma, the stoma problems are less common and the complaints are less.

dr. Frossard has performed a cost-effectiveness study on the use of the osseointegration prosthesis compared to the conventional socket prosthesis.

Download cost-effectiveness research

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