There are about 40 million amputees across the world. The standard solution for an amputee is a socket prostheseshave. However, socket prostheses are associated with poor range of motion, lack of stability and cause discomfort in a very large percentage of patients. Data demonstrate that between one in three and one in four of those expressing significant dissatisfaction with their prostheses report that they consider themselves to have a poor or extremely poor quality of life. That’s why it’s so important that these patients get a better alternative not only to sufficiently restore functioning but also to improve quality of their lives. Osseointegrated prosthetic implants have been developed over the past couple of decades to overcome the challenges posed by socket prostheses and provide a superior option for prosthetic patients.
Osseointegration is a revolutionary technology for lower or upper limb amputees, offering a viable solution for patients who have problems with traditional prostheses. The osseointegration implant rigidly attaches to the limb, which minimizes friction and provides a simple, fast and secure connection between the stump and the prosthesis. An osseointegrated limb consists of multiple components, which can be divided into implantable or non-implantable modules. A graftable implant is directly inserted into the remaining bone after amputation. A double-cone adapter connects the implant to the external prosthesis, which is further secured by an internal locking screw. Externally, the adapter is attached to a locking device with rotary mechanism control, which further connects to the prosthetic limb.
The surgical procedure is performed in a single surgery or in two separate surgeries depending on patient suitability. The bone canal is prepared using specialised instruments to accommodate the implant. The implant is then press-fitted into the canal tightly to achieve initial stability, which enables accelerated rehabilitation. The majority of the surgery involves soft tissue management where redundant skin, soft tissue, and fat are removed to minimise the bone to skin distance and reduce the risk of complications. Muscle groups are reoriented to serve a functional purpose in the leg, and the soft tissue fascial layer is approximated around the stem in a deliberate fashion. A layered closure provides the outcome of a refashioned stump with improved cosmesis. The surgeons then create a circular skin opening (the stoma) at the base of the stump overlying the tip of the implant. Through this opening, the dual cone adaptor is connected to the implant, which enables the remaining components and prosthetic limb to be attached externally. Loading through the implant begins a few days post-surgery, and the rehabilitation progresses to gait training shortly thereafter.
Hundreds of amputees have already benefited from osseointegration technology. Clinical studies confirm that the risk of complications is comparable to ordinary joint endoprostheses.
Unfortunately, traditional socket prosthesis is still associated with significant limiting factors that can be problematic for the amputee. Amputees often experience poor socket fit that is exacerbated by slight changes in weight. The use of fabric and silicone liners often causes excessive sweating and rubbing, which leads to chaffing, blistering and skin infections. Using a socket prosthesis is not without its psychological impact either. Amputees often show their disappointment and frustration with the socket prosthesis, especially with the advancement of robotic knee joint technology, which is hindered by the archaic interface with the stump.
Osseointegration nullifies most of these listed factors by virtue of the fact that it refers to the direct connection between the surface of a metal implant and living bone. Skin contact, tissue damage, and pain are minimized because the intramedullary metal implant attaches to the prosthetic via a small protrusion through the skin. Also, putting on and taking off the prosthesis is very easy and takes less than 10 seconds.
Specifically, those who undergo osseointegration tend to have improved walking proficiency, including the capacity to walk farther distances and for longer periods of time, owing to their ability to wear the prosthetic longer. Unlike with other prostheses, people report that osseointegrated prostheses feel like a part of them. This improved pressure and vibrotactile feedback is also associated with a greater freedom of motion. With an osseointegrated implant, the need to replace the funnel and associated materials is eliminated, reducing costs in the long run. Overall, the improved mobility and comfort that come with osseointegrated prosthetic devices increases patient satisfaction and prosthetic use, thus enhancing quality of life.
As with all surgical procedures, osseointegration surgery does have risks, despite the highest standard of practice. It is important that you have enough information about possible complications to fully weigh up the benefits, risks and limitations of the treatment. Serious complications are uncommon. The most common complication is infection and is discussed below:
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Rehabilitation generally involves 3 phases. You will be given thoroughinformation pre-operatively and be guided throughout your rehabilitation program.
Phase 1 involves the loading of a static weight by standing on a bathroom scale using a loading device attached to your implant. Loading takes place over a 20 minute period twice a day. This may commence as soon as the next day after surgery and continues until you achieve 50% of your bodyweight or 50kg. You will begin loading at 5kg with the speed of advancement determined by your bone quality measured through pre-operative DEXA scans and intra- operative bone quality assessments.
Phase 2 applies only to above-knee amputees and involves getting fitted with a light leg for gait training. You will start taking your first steps aided by parallel bars and when it is safe, progress to using two crutches.
Phase 3 involves the fitting and alignment of your definitive prosthesis. Once fitted, you will be allowed to walk with two crutches for 6 weeks, followed by one crutch for another 6 weeks then unaided thereafter. This is necessary to minimise the risk of falls and prevent premature overloading of the implant.
