Feasibility study on using smart templates for socket fitting (V2)
Research type
Research Study
Full title
Feasibility study on using smart templates, that link rectification approaches to particular patient characteristics, for socket fitting
IRAS ID
313408
Contact name
Alex Dickinson
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
Research Summary:
Prosthetic socket comfort and fit is important in ensuring individuals with amputation can get the most use from their prosthetic limb. Researchers from the University of Southampton and spin out company Radii Devices have been developing underlying technology based upon cutting-edge engineering design to meet the patient and clinic need, guided by input from prosthetics service providers (including Opcare Ltd) and patients. This study is assessing the feasibility of underlying technology of a future design software: using a ‘smart template’ for designing the check socket which is used to assess fit, before a definitive prosthetic socket is produced. These smart templates use historical socket fitting data, which is analysed to link rectification approaches to particular patient characteristics.The aim of this study is to compare a check socket designed by a clinician (known as a prosthetist) and a check socket designed by the smart templates. This will enable understanding of the strengths and limitations and inform development of a future evidence-based design software for prosthetists that provides optimal socket design support alongside the expertise and experience of the clinician to achieve a comfortable result, quicker.
This study is funded by an Innovate UK Biomedical Catalyst grant and will be carried out over a 6 month period at Oxford, Roehampton and Bristol Opcare NHS prosthetic services. Prosthetists at these services and patients with a below-knee amputation will be eligible to apply if they are interested. Participation will be split into two stages. In Stage One participants will be asked to trial two check sockets (designed using different methods) at their fitting appointment instead of the usual one. If participants would like to participate in the second stage they will be asked about their experiences of socket fit and comfort in interviews, and within a short socket comfort diary for patients.
Lay summary of study results:
Background: Personalized prosthetic socket design depends upon highly skilled healthcare professionals called ‘prosthetists’. They aim to balance:a firm, functional coupling between the human and their prosthesis with
safe, comfortable load transmission from the prosthesis to the skeleton,
through vulnerable skin and soft tissues. Both the traditional approach, which used plaster casting by hand, and the state-of-the-art computer-aided design and manufacturing (CAD/CAM) method, are iterative, and sharing knowledge is difficult.
Evidence-generated (EG) sockets derived from digital records generated during past computer-aided socket design (CASD) practice could provide a personalized starting point for limb fitting, potentially reducing time spent on basic design and enabling prosthetists to focus on more highly-skilled, personal design customization.
Objective: This study aimed to assess the comfort of EG sockets, generated from past CASD records. It was a ‘noninferiority’ study, which aimed to check that the new EG method performs no worse than the CAD/CAM ideal clinical standard method, on the basis that future research would evaluate any perceived additional benefits, such as direct and indirect cost savings.
Methods: This trial compared EG sockets, derived from 163 previous transtibial devices, with conventional clinician-led CAD/CAM sockets. We used a ‘crossover’ approach, meaning that our participants all tried both sockets and compared them. Noninferiority was assessed for the socket comfort score (SCS), and semi-structured interviews provided in-depth user analysis. The setting was 3 UK National Health Service clinics, with 17 participants with 19 transtibial amputations; i.e. two participants had amputations on both legs.
Results: EG sockets had no significant difference in comfort compared with clinician-led control sockets (median SCS 8.6 for EG sockets and 8.8 for CAD/CAM controls; P=.43, effect size=0.05), but were less variable in comfort across the group (95% confidence interval in SCS 8.0‐9.0 for EG and 7.5‐9.5 for CAD/CAM devices, respectively). Analysis of interviews revealed themes around the participants’ fitting session experiences; similarities and differences between the EG and CAD/CAM control sockets; and residual limb factors impacting the socket comfort that they perceived. These provided insights into the participants’ experience of the study, and the value of expert prosthetist input in socket design.
Conclusions: EG sockets demonstrated noninferiority to conventional clinical computer aided socket design practice in terms of socket comfort. Both quantitative and qualitative results indicated how clinician input remains essential and is valued by prosthesis users. Work is underway to incorporate the EG sockets into CASD software such that they can act as a digital starting point for modification by expert clinicians at prosthetic limb design and fitting, potentially reducing time spent on basic design, enabling prosthetists to focus on more highly-skilled customization and co-design with their patients.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
22/YH/0215
Date of REC Opinion
4 Oct 2022
REC opinion
Favourable Opinion