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
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.
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