Researchers from Radii Devices and the University of Southampton have made a groundbreaking advancement in the field of prosthetics with the introduction of a novel, data-driven way to design and fit below-the-knee prosthetic limbs. This innovative approach is poised to revolutionize the way prosthetics are tailored to individual patients, offering benefits in terms of both time efficiency and cost effectiveness. The findings from an NHS trial will be published in the journal JMIR Rehabilitation and Assistive Technology, highlighting the promise of this new technology in enhancing the lives of amputees.
In traditional prosthetic fitting processes, patients often endure a time-consuming journey characterized by multiple appointments and iterative fittings. Constituting a critical component of prosthetic design, the socket must be meticulously crafted to ensure comfort, stability, and safety. It directly bears the weight of the user throughout various activities, necessitating a precise balance to effectively distribute forces and minimize discomfort or potential harm to the residual limb. Conventionally, prosthetists would capture the limb’s shape through plaster casts or modern computer-aided design (CAD) software, generating trial versions before arriving at a final product. This new method stands to change all that, offering a data-driven alternative that streamlines the design process significantly.
At the heart of this innovative approach lies the software developed by Radii Devices, which leverages an extensive database collected from numerous previous socket designs. By analyzing historical data and identifying patterns in relation to various patient characteristics—such as limb shape and size—this software is capable of rapidly producing a preliminary design recommendation grounded in statistical success benchmarks. Patients will experience a faster and more efficient design process, which could potentially ease the backlog of waiting lists observed in the healthcare system and improve patient satisfaction.
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The clinical trial conducted by the researchers involved seventeen participants from multiple NHS prosthetic rehabilitation centers. Each patient was fitted with both a conventional prosthetic socket designed by a trained prosthetist and a socket generated using the new software. Participants were then asked to evaluate the comfort of the sockets, providing ratings on a scale of one to ten. The results demonstrated a remarkable finding: while the comfort scores for both socket types were statistically similar, the data-driven sockets exhibited greater consistency in performance across the cohort, signifying an advancement not merely in speed but in reliability.
Importantly, patient feedback indicated a favorable response towards the data-driven socket designs, with some participants expressing a preference for them and ultimately transitioning to these models as their final prosthetic limbs. This creates a compelling case for integrating such data-driven designs in standard clinical practice while still maintaining the indispensable role of skilled prosthetists. The research team posits that this technology should serve as a foundational tool that prosthetists can refine further, focusing their expertise on individual nuances that are critical for achieving the perfect fit.
Dr. Joshua Steer, the Founder and CEO of Radii Devices, emphasized the transformative potential of their work. By underpinning the design process with empirical data, prosthetists can expedite fittings without compromising the customized care that patients have come to expect. The complexity of the human body necessitates professional input—such as identifying tissue characteristics and the presence of bone spurs—so while the software expedites the design, the expert touch remains vital for addressing intricate patient needs.
The implications of this technology extend beyond individual patients; nearly one hundred prosthetic limbs have already been fitted using this new approach, demonstrating its applicability and effectiveness in real-world settings across both the UK and the USA. With a collective effort from physiotherapists, health scientists, and software engineers, this multidisciplinary team has crafted a system that taps into a wealth of existing knowledge while innovatively addressing current limitations in prosthetic design processes.
This initial study serves as a proof of concept for what could be a transformative shift in how prosthetics are approached. Instead of relying solely on individualized artisan processes, data becomes an invaluable ally, contributing to faster fittings, success rates, and ultimately, quality of life for users. Future research may delve deeper into expanding the datasets to create even more refined models, further enhancing the adaptability of this technology across a broader range of patient conditions.
Maggie Donovan-Hall, a co-author of the study with expertise in psychology in prosthetics and orthotics, highlighted the study’s efforts to assess the worst-case scenario, wherein design recommendations were made without input from experienced prosthetists. The positive outcomes observed in this trial underscore the method’s robustness and lay the groundwork for further integration of these data-driven designs into clinical workflows. By freeing up valuable time for prosthetists, this technology envisions a world where they can devote more attention to perfecting the personalized aspects of each design that are crucial for patient satisfaction.
As the project moves forward, the next steps involve developing a user-friendly software interface that enables clinicians to seamlessly incorporate data-driven designs into their practices. This collaborative approach aims to ensure that as technology evolves, it does so in a manner that enhances, rather than replaces, the irreplaceable skill and knowledge of prosthetists.
With ongoing support from funding bodies such as Innovate UK, the Royal Academy of Engineering, and Orthopaedic Research UK, the pioneer research represents a significant step forward in the quest for better prosthetic solutions. Amplifying the impact of the findings, the study is set to be published in a highly respected journal, setting the stage for discussions that may influence future practices in prosthetic rehabilitation.
The integration of data into prosthetic design marks not only an advancement in technology but a holistic improvement in healthcare, where data-driven solutions could reshuffle the existing paradigms of medical device fitting and adjustment. Enhancing patient experiences and outcomes while alleviating the burdens on healthcare professionals encapsulates the spirit of innovation driving this endeavor forward.
This revolutionary technology encapsulates the promise of transforming the lives of amputees, making prosthetic limbs more accessible, comfortable, and tailored than ever before, navigating toward a future where each individual walks with confidence and support.
Subject of Research: People
Article Title: Evidence-Generated Sockets for Transtibial Prosthetic Limbs Compared With Conventional Computer-Aided Designs: A Multiple-Methods Study From the Patient’s Perspective
News Publication Date: 21-Aug-2025
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Image Credits: Dr Jenny Bramley / Radii Devices Ltd.
Keywords
Tags: 3D printing in prostheticsadvancements in amputee rehabilitationbelow-the-knee prosthetics innovationcomfort and stability in prosthetic limbscost-effective prosthetic solutionsdata-driven prosthetic designefficient prosthetic fitting processimpact of technology on prostheticsJMIR Rehabilitation and Assistive Technology publicationNHS trial findings on prostheticspersonalized prosthetic technologysocket design and limb comfort