Feasibility Study on Using Smart Templates, That Link Rectification Approaches to Particular Patient Characteristics, for Transtibial Prosthetic Socket Fitting

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 a spin out company Radii Devices Ltd have been developing software based upon the cutting-edge of engineering design to support clinicians in the design of the socket.

The technology uses data from previous socket designs and limb shapes to develop and train the software, developed working with Opcare Ltd, a prosthetics provider. The software suggests appropriate socket design shapes (templates) that may be optimal based on previous designs and whether they have fit and been comfortable.

The aim of this study is to assess the feasibility of sockets designed by the Radii Devices software, and a preliminary comparison against socket designed by a clinician (known as a prosthetist). Combining qualitative (semi-structured interview) and quantitative (Socket Comfort) methods, will enable understanding of the strengths and limitations and inform further development of the Radii Devices technology into full design software for prosthetists that provides optimal socket design support.

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 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.

Conditions

• Transtibial Amputation
• Prosthetic

Interventions

DEVICE

Smart template - designed prosthetic check socket

Evidence-generated trial prosthetic sockets are designed automatically by performing machine learning analysis of past socket designs that were produced by expert clinicians, the participant's residual limb size and shape descriptors and patient descriptors

DEVICE

Clinician-designed prosthetic check socket

Active comparator prosthetic sockets are designed by expert prosthetists, bespoke to the participant, in a computer aided design environment (CAD)

Sponsors & Collaborators

• Radii Devices Ltd

  collaborator UNKNOWN

• Opcare Ltd

  collaborator UNKNOWN

• University of Southampton

  lead OTHER

Principal Investigators

• Alexander Dickinson, PhD · University of Southampton

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-17

Primary Completion

2023-11-14

Completion

2023-11-30

Countries

• United Kingdom

Study Locations