The data-driven fittings for below the knee prosthetics were, on average, as comfortable for patients as those created by highly skilled prosthetists, the NHS trial suggested.
Technology developed by Radii Devices and the University of Southampton is hoping to halve the number of clinical visits for the fitting from an average of four to two using the software.
The new technology is built to provide a personalised “socket” using data from other fittings and a 3D scan of the residual limb to immediately generate a basic design.
The CEO and founder of Radii Devices, Dr Joshua Steer, said analysing hundreds of previous sockets allowed them to “identify trends” between different patient characteristics.
“We can then scan a new patient’s residual limb and generate a personalised design recommendation based on features that have been successful for similar patients in the past,” he explained.
The results of an NHS trial published on Friday in JMIR Rehabilitation and Assistive Technology suggest the new designs are on average as comfortable as those created by a prosthetist.
Nineteen sockets were made for 17 participants, as two participants were double amputees, and all bar one of the sockets were above the “NHS comfort score target”, the Radii Devices CEO said.
Of those 19 sockets, six of the new designs were reportedly more comfortable than normal prosthetics, while five were less and eight were very similar.
Prosthetic sockets are personalised to ensure they are comfortable and functional, as they need to bear a person’s body weight without damaging limb tissue or creating discomfort.
Traditionally, a prosthetist makes a plaster cast of the leg and reshapes it to produce a socket which achieves the right balance, producing trial versions before settling on a definitive one.
Radii Devices says the NHS currently tries to deliver a prosthetic in four clinical visits roughly a month from their first appointment, while the new system can aim for a “gold standard” of two appointments.
Alex Dickinson, Professor of Prosthetics Engineering at the University of Southampton – who helped to develop the new method, acknowledges that it has limits.
He said: “Only a highly skilled prosthetist can identify things like bone spurs and neuromas, and know how to tweak designs to avoid causing pain or damage at these sensitive areas.
“We developed the data-driven socket design approach to save prosthetists’ time by giving them a solid base to work from so they can use their expertise where it is most valuable, in making precise adaptations tailored to their patients’ specific needs.
“The method effectively helps prosthetists to learn from each other.”
Another co-author, Professor Maggie Donovan-Hall, said it was “surprising and encouraging” that the data-driven sockets performed so well in a test designed as a “worst case” scenario where they received no additional input from prosthetists.
Nearly 100 people have now had a prosthetic leg designed this way, across multiple centres in the UK and the USA.
The study has now moved into its final stage where the new software is developed alongside clinicians to see how it can be best incorporated into their practices.