Currently submitted to: JMIR Rehabilitation and Assistive Technologies
Date Submitted: Sep 11, 2026
Open Peer Review Period: Sep 22, 2026 - Nov 17, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Clinical and Functional Outcomes of 3D-Printed versus Conventionally Fabricated Transtibial Prosthetic Sockets: A Comparative Cross-Sectional Study
ABSTRACT
Background:
Background:
By 2040, the population is projected to exceed 38.5 million, of whom approximately 200,000 are expected to live with a physical disability. Prostheses enable individuals with physical impairments to lead healthier and more productive lives, actively participate in social activities, and most importantly restore their autonomy. However, high rejection rates of prosthetic devices primarily driven by socket discomfort and dissatisfaction with aesthetics remain a pressing clinical and rehabilitative concern. Three-dimensional (3D) printed prosthetics offer the possibility of greater customisation, enhanced comfort, and improved cost efficiency compared with conventionally fabricated alternatives.
Objective:
Objective:
The present study aimed to evaluate patient-reported outcomes of 3D-printed transtibial prosthetic sockets in comparison with those produced through conventional methods.
Methods:
Methods:
A retrospective cross-sectional study was conducted among 30 adult patients (aged ≥18 years) with transtibial amputation who met predefined inclusion and exclusion criteria. The Orthotics and Prosthetics Users' Survey was used to evaluate patient satisfaction with the prosthesis and related services, lower-limb functional status, and health-related quality of life.
Results:
Results:
Compared with conventionally fabricated sockets, 3D-printed transtibial sockets were associated with significantly better lower-limb functional outcomes (p<0.001) and higher patient satisfaction (p=0.013), whereas the health-related quality-of-life index did not differ significantly between the two socket types (p=0.213).
Conclusions:
Conclusion: 3D-printed transtibial sockets yielded superior lower-limb functional status and greater patient satisfaction than conventional sockets, while health-related quality of life showed the smallest difference across the three OPUS domains. The favourable aesthetics, ease of fitting, lightweight construction, and capacity of additive manufacturing to adjust socket dimensions in support of lower-limb symmetry underpin the clinical promise of this technology. Further randomised controlled trials are warranted to evaluate the comparative effectiveness of different 3D-socket manufacturing methods and their impact on patient-centred outcomes.
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