Osseointegration: the super-human frontier of amputation medicine
This article was co-authored by Stephen Foster, Senior Associate, Kennedys, Matija Krkovic, Consultant Orthopaedic Trauma Surgeon and Abdo Haidar, Prosthetist, London Prosthetics Centre
Osseointegration or direct skeletal fixation (DSF) is an alternative method of attaching a prosthesis to an amputee’s body and involves a titanium rod being inserted directly into the bone. The process therefore eliminates the need for a traditional socket. It was originally developed in the 1990s by Professor Branemark in Sweden but has been significantly developed in recent years to the point that it is now a genuine and viable option for most upper and lower amputees.
There are now various surgical centres located around the world including Australia, Germany, the Netherlands, Sweden and the United States. Whilst the process is not currently available in the UK on the NHS, there are several private centres, two of which have opened in the last 18 months.
There has been a recent increase in the number of amputees considering, and ultimately opting for, the surgery. In this article we will look at why there is a growing trend, how this plays out in reality and what this means from a claims perspective. In doing so we will get the views of an orthopaedic surgeon who has trained to carry out osseointegration and a prosthetics expert who clinically treats amputees who have undergone the surgery.
Matija Krkovic: the surgeon’s view
There are restrictions on those who are deemed suitable for the surgery as it is an intrusive surgery. It is generally deemed suitable for those that have reached full skeletal maturity (therefore ages 20 to 69) and those people that are not satisfied with traditional socket technology. Most centre across the world will only consider osseointegration for amputees with a body weight of less than 100kgs and who are non-smokers, with no history of osteoporosis. Before definitive preoperative preparation, all potential patients will be reviewed by psychologist. Particular attention will be paid to uncover any potential hidden psychological condition which can potentially lead to either underestimating consequences or overestimating the benefits of the procedure.
Despite the recent developments in the process, there is still no uniform approach to the surgery process across the world. Most centres perform a two-stage surgery and this is the case at Cambridge Osseointegration Clinic at Nuffield Health Cambridge hospital, where the first stage typically takes place 4-8 weeks before the second stage. In Australia, a single stage surgical process is adopted. Whilst we are aware of the controlled randomised trial being conducted in Australia comparing the two stage versus single stage procedures, the results have not been published yet.
Pre and post-operatively, patients will be seen regularly by a physiotherapist experienced with osseointegration procedures. Post-operative X-rays will be taken when the patient is comfortable. Depending on the stability of the stem, they will be advised on partial or full weight bearing. At this stage, patients will not be able to wear socket prosthesis anymore.
Length of the bone stump will directly correlate with the functional outcome. The longer the stump of bone with muscular attachment is, the better the function from the prosthetic limb can be expected.
Following standard and established early post-operative osseointegration mobility protocols, there is likely to be a need for continual physiotherapy over the following months. Clinically, patients will be followed up with after at least 6 weeks, and then after 3 months, 6 months and 12 months postoperatively; at which stage it takes place.
Abdo Haidar: the prosthetists view
The amputees that I see in clinic, that have undergone osseointegration, have chosen the surgery because they are seeking improved comfort and/or increased functionality. Generally speaking, the surgery has led to an improved connection, reduced skin breakdown and skin problems caused by wearing a socket, improved comfort, a more stable socket/residual limb fixation, increased use of the prosthesis, improved mobility (increased prosthetic usage time and distance) and easier donning. In turn, this has led to increased levels of independence and less attendance to the clinic.
However, there are problems as the process is still in its infancy and the long term effects are still largely unknown. There have been less than 2,000 amputees that have undergone the surgery since the 1970’s and there have been numerous reported problems, such as infection and soft tissue irritation at the stoma, fractures, fatigue of metal, issues with the prosthetic connectors and loosening of the implant.
The costs of the surgery varies according to where it is carried out. However, it is usually in the region of between £40,000 - £80,000 for the surgery alone, depending on complexity and the team/country where the surgery is likely to take place. The interface components typically cost in the region of between £4,000 - £5,000 and need to be replaced approximately every 2-3 years. In addition, there is the cost of the aftercare and rehabilitation.
Conclusion – how will this affect amputation claims?
The future remains unclear regarding osseointegration, but the changes in implant design, surgical technique, pre and post-surgery care and rehabilitation protocols have resulted in improvements of functional outcomes and quality of life. From the limited available research, it also appears that there has been a reduction in complications post-surgery. It is now largely considered that for some amputees the benefits of osseointegration outweigh the acceptable clinical risks and it is becoming an established clinical treatment for those not tolerating traditional socket prosthesis. The indications are currently that the process will continue to become more widely available as better and wider research and a greater sharing of information between the providers occurs. The initial costs can be significant, including the surgery, any associated international travel, and the post-operative rehabilitation programme. However, if done successfully the procedure may pay for itself in terms of better functional outcomes resulting in reduced care needs, and lower rolling costs because annual socket revision or maintenance is no longer required.