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Research on prosthetic sockets for lower limb amputees

A European collaborative project to improve quality of life for users of prosthetic limbs is about to launch with TWI at the helm. TWI is one of eight consortium partners who will be working on SocketMaster, a multimillion-euro research project that promises to provide amputees with personalised, optimised prosthetic sockets capable of being designed and manufactured in a short time period.

The need for improvements

In developed countries, more than 90% of limb amputees achieve their mobility through the use of prostheses. The comfort of a prosthetic limb is a key consideration for both manufacturers and service providers, as they are keen to help the prosthetic limb user – who will have to wear the prosthetic indefinitely – regain a good quality of life.

Medical problems due to the operation of the prosthetic limb are intensely frustrating to the user and reduce the desirability of specific prosthetic devices.

The function of a lower limb prosthetic is highly dependent upon the characteristics and anatomical profile of the residual limb. This is unique to each individual and changes depending on the activities being engaged in by the amputee.  A poorly fitting prosthetic socket can cause significant trauma, so it is important to consider how to optimise the fit to maximise the amputee's comfort whilst wearing the limb prosthesis.

Extensive training and experience is required before a prosthetist can capably design a proper load-bearing characteristic for a specific residual limb. Nevertheless, the current design approach of prosthetists is highly subjective, and sockets are made without access to comprehensive information related to the comfort of an amputee, such as friction and moisture levels. This means that the current practice is not only time-consuming, but also highly dependent on the experience of the prosthetist.

Working together to make a change

To overcome the challenges, TWI is leading a consortium of eight partners from Greece, Italy, Poland, Portugal and the UK to develop a new technique, entitled SocketMaster. The consortium aims to integrate various micro sensors into a master socket, which will help prosthetists achieve fast, customised design and manufacturing of prosthetic sockets for lower limb (trans-femoral and trans-tibial)  amputees.

It is expected that by wearing the master socket, comprehensive data characteristics of the patient during typical activities will be able to be measured and collected. This data will then be used to optimise the socket design to maximise the patient’s comfort. The digital 3D data of the optimised socket design will be fed into a rapid prototyping machine for fast fabrication.

At least 50 clinical trials will be carried out to validate the SocketMaster technique. It is envisaged that SocketMaster will enable same-day socket fabrication with optimised quality, and the fit and function of the prosthetic socket will be less dependent on the skills of the prosthetist.

The project and partners

The SocketMaster project has won 4 million euros of funding from the European Commission’s newly launched Horizon 2020 Research and Innovation programme, under the theme of ICT-2: Smart Systems Integration. The proposal got a high evaluation score of 14.5 out of 15, with two full marks in the ‘excellence’ and ‘impact’ sections.

The project will start on 1 February 2015 and last for three years. It is the first major collaborative research project that TWI will co-ordinate on medical devices under the new EU research programme. It will involve extensive clinical trials and require the appointment of an external independent ethics adviser.

The eight consortium partners are: Innora (Greece), Fondazione Bruno Kessler (Italy), Veneto Nanotech SCPA (Italy), Polkom Badania SP ZOO (Poland), Sensing Future Technologies Lda. (Portugal), University of Surrey (UK), Hugh Steeper Limited (UK), and TWI.

For further information, please email contactus@twi.co.uk