CompletedInterventional

Clinical usability evaluation of an adaptive templates fitting system for socket design

This study is looking at a new computer system, ATFS, which helps specialists design artificial leg sockets. When someone loses a limb, getting a comfortable, well-fitting socket is really important. The new ATFS tool uses computer models and past information to help prosthetists (the specialists who make artificial limbs) create better sockets. The main goal is to see how easy the ATFS tool is to use in real NHS clinics and if it can make the process of designing sockets more efficient. The study involves both prosthetists and adults who have had a lower leg amputation, looking at how the tool works and how it affects socket comfort and fit.

At a glance

Status

Completed

Sponsor

Radii Devices Ltd

Enrolment target

Start

20 Jan 2025

Estimated completion

24 Mar 2026

Prosthetic socket design

What is this study about?

Imagine you've lost a leg, and you need an artificial one. The part that connects your body to the artificial leg is called the socket. It's super important that this socket fits perfectly, like a good shoe, so you can move around comfortably without pain or rubbing. But designing these sockets is really tricky and takes a lot of skill and time.

The NHS helps thousands of people every year who need artificial limbs. Because designing sockets is so complex, there can be long waits, and sometimes people aren't happy with how their socket fits. To help with this, some clever researchers have developed a new computer tool called the Adaptive Templates Fitting System (ATFS). Think of it like a smart design assistant for the specialists who make artificial limbs (called prosthetists).

This study is all about testing this new ATFS tool. We want to see if it makes it easier and quicker for prosthetists to design better-fitting sockets. This could mean more comfortable artificial limbs for patients, less waiting time, and overall better care. It's a real-world test to see if this new technology can make a difference in NHS clinics.

Key takeaways

The study tests a new computer tool (ATFS) for designing artificial leg sockets.
It aims to improve socket comfort and speed up the design process for NHS patients.
Both specialists (prosthetists) and patients with below-knee amputations are involved.
Participation involves using the new tool as part of regular NHS care.
Potential benefits include better-fitting sockets and faster delivery of artificial limbs.
Risks are low, and you can withdraw from the study at any time.

Who may be eligible?

This study is looking for two main groups of people. First, they need prosthetists (specialists who design artificial limbs) who work in specific NHS centres in Bristol, Cambridge, or Norwich. These prosthetists should already know how to use computer-aided design (CAD) software for their work.

Second, the study is inviting adults who are 18 years or older and have had an amputation below the knee. These patients should be due to get a new artificial leg as part of their usual NHS care. It's important that they can understand English and are able to talk about how their socket feels to them.

Some people may not be able to join. For example, prosthetists who aren't familiar with computer design software for sockets, or patients who can't receive a prosthetic socket for medical reasons, would not be suitable for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an amputation below the knee (transtibial)?
Are you due to get a new artificial leg as part of your regular NHS care?
Can you understand English and talk about how your artificial leg socket feels?

Answer every question to see your result.

What does participation involve?

If you join this study, it will be part of your usual care at the NHS clinic. For patients, you would receive an artificial leg socket that is designed using the new ATFS system, rather than the standard method. You would still have your regular appointments and care. Prosthetists involved would receive training on how to use the ATFS tool and would then use it to design sockets for patients during their normal working day. Researchers would observe them and ask for feedback.

The study has two stages. In the first stage, prosthetists will use the tool, and give feedback so it can be made even better. In the second stage, prosthetists will use the improved ATFS on their own. This study is expected to run until December 2025.

Potential risks and benefits

There aren't any direct health benefits for people taking part, but the study could lead to big improvements in how artificial limbs are made in the future. This might mean more comfortable sockets, quicker design times, and faster delivery of artificial limbs for many people. The risks are very low because this study is happening within standard NHS care. If you experience any discomfort or problems with your socket, these will be handled by the NHS, just as they normally would be. Everyone involved will be asked to give their permission to take part and can leave the study at any time without changing their care or job.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

North Bristol NHS Trust
City only
Bristol, England
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke’s Rehabilitation Clinic
City only
Cambridge, England
Norfolk Community Health and Care NHS Trust, Re-enablement Services Centre
City only
Norwich, England

Common questions

What is a 'prosthetic socket'?

It's the custom-made part that connects someone's remaining limb to their artificial leg or arm. It's like a special cup that holds the limb.

What is the ATFS tool?

It's a new computer program that helps specialists design prosthetic sockets better and faster, using past information and computer models.

Who is running this study?

It's a joint effort by researchers at the University of Southampton, Radii Devices Ltd., and NHS prosthetic centres in Bristol, Cambridge, and Norwich.

Will I get a new artificial leg if I join?

If you are a patient participant, you will be due a new artificial leg as part of your usual care, and its socket will be designed using the ATFS tool.

Can I stop being part of the study anytime?

Yes, you can leave the study at any point without it affecting your care from the NHS or your job.

How to find out more

Joshua Steer

rosalynne@radiidevices.com +44 7766708201 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.