Evidence map›Paper›PMID 40840190›Full record

ArticleJMIR rehabilitation and assistive technologies2025

Evidence-Generated Sockets for Transtibial Prosthetic Limbs Compared With Conventional Computer-Aided Designs: A Multiple-Methods Study From the Patient's Perspective.

Florence Mbithi, Maggie Donovan-Hall, Jennifer Bramley, Joshua Steer, Charalambos Rossides, Peter Worsley, Chantel Ostler, Cheryl Metcalf, Dominic Hannett, Caroline Ward and 8 more

Abstract read
In one paragraph

Article in JMIR rehabilitation and assistive technologies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Florence MbithiMechanical Engineering Department, University of Southampton, Mailpoint M7, University Road, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380595394.ORCID http://orcid.org/0000-0002-6103-7996
Maggie Donovan-HallMechanical Engineering Department, University of Southampton, Mailpoint M7, University Road, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380595394.ORCID http://orcid.org/0000-0003-3398-845X
Jennifer BramleyRadii Devices Ltd, Bristol, United Kingdom.ORCID http://orcid.org/0000-0003-0414-3984
Joshua SteerRadii Devices Ltd, Bristol, United Kingdom.ORCID http://orcid.org/0000-0002-6288-1347
Charalambos RossidesRadii Devices Ltd, Bristol, United Kingdom.ORCID http://orcid.org/0000-0002-7547-0256
Peter WorsleyMechanical Engineering Department, University of Southampton, Mailpoint M7, University Road, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380595394.ORCID http://orcid.org/0000-0003-0145-5042
Chantel OstlerPortsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.ORCID http://orcid.org/0000-0002-8267-2892
Cheryl MetcalfMechanical Engineering Department, University of Southampton, Mailpoint M7, University Road, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380595394.ORCID http://orcid.org/0000-0002-7404-6066
Dominic HannettOpcare Ltd, Abingdon, United Kingdom.ORCID http://orcid.org/0009-0001-4352-4598
Caroline WardOpcare Ltd, Abingdon, United Kingdom.ORCID http://orcid.org/0009-0009-8378-2506
Jack KitchenOpcare Ltd, Abingdon, United Kingdom.ORCID http://orcid.org/0009-0006-8369-6593
Sioned SteventonOpcare Ltd, Abingdon, United Kingdom.ORCID http://orcid.org/0009-0001-1929-2715
Katy McIntoshOpcare Ltd, Abingdon, United Kingdom.ORCID http://orcid.org/0009-0007-3457-6111
Shigong GuoNorth Bristol NHS Trust, Bristol, United Kingdom.ORCID http://orcid.org/0000-0003-3227-5503
Helen HarveyNorth Bristol NHS Trust, Bristol, United Kingdom.ORCID http://orcid.org/0009-0008-1824-1685
David Henderson SlaterOpcare Ltd, Abingdon, United Kingdom.ORCID http://orcid.org/0000-0003-4650-3888
Vijay KolliSt George's Hospital, London, United Kingdom.ORCID http://orcid.org/0009-0006-8302-3559
Alex DickinsonMechanical Engineering Department, University of Southampton, Mailpoint M7, University Road, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380595394.ORCID http://orcid.org/0000-0002-9647-1944

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Personalized prosthetic socket design depends upon highly skilled prosthetists. They aim to balance functional human-prosthesis coupling with safe, comfortable load transmission from the prosthesis to the skeleton, through vulnerable skin and soft tissues. Both traditional plaster and computer-aided design and manufacturing (CAD/CAM) methods are iterative, and sharing knowledge is difficult. Evidence-generated (EG) sockets derived from past computer-aided socket design (CASD) records 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 customization. Objective: This study aimed to assess the comfort of EG sockets, generated from past CASD records. Methods: A crossover trial compared EG sockets, derived from 163 previous transtibial devices, with conventional clinician-led CAD/CAM sockets. Noninferiority was assessed for the socket comfort score (SCS) outcome measure, and semistructured interviews provided in-depth user analysis. The setting was 3 UK National Health Service clinics, with 17 participants with 19 transtibial amputations. Results: EG sockets had no statistically 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 a lower variability in SCS across the group (95% CIs 8.0-9.0 for EG and 7.5-9.5 for CAD/CAM devices, respectively). Analysis of interviews revealed themes around fitting session experiences, similarities, and differences between the EG and CAD/CAM control sockets, and residual limb factors impacting perceptions of socket comfort. 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 CASD 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 fitting, potentially reducing time spent on basic design, enabling prosthetists to focus on more highly-skilled customization and co-design with their patients.

Indexed as

CAD/CAMcomputer aided design and manufacturingevidence-based practiceprosthetic socket designqualitative researchtranstibial

Identifiers

PMID40840190
PMCPMC12370269

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.