Is an osseointegration (click) prosthesis safe?
For patients with a leg amputation who experience problems wearing a socket prosthesis, there is now a method to anchor the prosthesis to the body. Through the skin, the surgeon can insert an orthopaedic implant directly into the bone of the stump. The artificial bone can be connected to this implant using a click system. This technique is called osseointegration, and the prosthesis is therefore called click prosthesis. Doctors use the term osseointegration prosthesis or bone-anchoring prosthesis. The skin opening through which the implant protrudes is called stoma.
What is the principle of osseointegration?
The osseointegration prosthesis comes from dentistry. In the 1960s, a Swedish scientist Brånemark discovered that bone bonds very well with the surface of a titanium screw. This connection of metal with bone is called osseointegration, and this principle is now used by orthopaedists to apply hip and knee prostheses to the bone on a large scale. Since the 1990s, this osseointegration technique has been further developed for people with an arm or leg amputation. Unlike a hip or knee prosthesis, here the implant protrudes through the skin so that an artificial arm or leg can be clipped 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. Surgeon Dr Jan Paul Frölke and rehabilitation specialist Dr Henk van de Meent and their research team at Radboudumc Nijmegen, in collaboration with other major centres around the world, have followed all patients they have treated with osseointegration prosthesis since 2009. Not only have they investigated the benefits of this treatment, but they have also identified the disadvantages and possible complications. Initially, it was thought that the implant would give rise to infection of the bone and loosening of the implant. Research published in US international scientific journals showed in the first 84 patients with an osseointegration prosthesis that the risk of loosening is very small. In 1 patient, the implant loosened and had to be replaced. Follow-up studies could confirm this, but more than two-thirds of people were found to have regular ostomy irritation and ostomy infections. Particularly in people who smoked and those with high body weight. However, the ostomy symptoms were easily treatable and often transient. Due to recently developed new surgical techniques, ostomy problems are now rare and the symptoms are fewer. Ostomy complaints are now seen mostly in the first two years after surgery.
What are the advantages of an osseointegrated (click) prosthesis?
The advantages of the osseointegration (click) prosthesis over the socket prosthesis were found to be significant after only one year, but this improvement also continues after two and five years. From studies in the first patients treated in the Netherlands, prosthesis wearing time increased significantly, walking distance increased and walking also took less energy. Quality of life increased and X-ray examination of the bone showed that the bone of the stump became stronger and thicker. A major advantage of the osseointegration prosthesis is that it is stably anchored to the bone. As a result, people feel more secure, can sit and cycle better, and in summer they do not suffer from perspiration. Another interesting advantage is that people with an osseointegrated prosthesis can feel the ground. The vibrations that occur when walking over a smooth or non-slippery surface are sensed through the implant in the bone. This phenomenon is called osseoperception (feeling with the bone) and gives the person with an osseointegration prosthesis the feeling of having his or her own leg back.
What are the risks of an osseointegrated (click) prosthesis?
The medical specialists at AOFE Clinics have followed all the patients they have treated with osseointegration prostheses since 2009. They have studied the benefits and risks of an osseointegration prosthesis. Initially, it was thought that an implant protruding out through the skin would give rise to infection of the bone and loosening of the implant. This study of the first 84 patients with an osseointegration prosthesis showed that the risks are very small. The implant detached from the bone in 2% of the cases and had to be replaced. Stoma irritation and stoma infections do occur, especially in people who smoke and those with high body weight. The ostomy symptoms are treatable and are often transient. Due to recently developed new surgical techniques for inserting the stoma, ostomy problems are now rare and the number of complaints have also decreased.
Dr Frossard conducted a cost-effectiveness study on the use of the osseointegrated prosthesis compared to the conventional socket prosthesis.