Abstract

Background: Additive manufacturing (AM) has gained increasing attention in prosthetics and orthotics (P&O), yet real-world evidence on its clinical and operational value remains limited, particularly across both prosthetic and orthotic device classes within tertiary hospital practice. This study evaluated the comparative performance of AM in transtibial prosthetic sockets and ankle-foot orthoses (AFOs) within Singapore’s public healthcare setting. Methods: Two comparative clinical evaluations were conducted. The transtibial socket component used a prospective two-period cross-over design across two P&O departments in NHG Health hospitals, comparing digitally fabricated Multi Jet Fusion (MJF) sockets against conventionally laminated sockets. The AFO component compared posterior cut-out MJF AFOs against conventional polypropylene AFOs within a tertiary hospital P&O service. Patient-reported outcomes were assessed using the Prosthesis Evaluation Questionnaire (PEQ) and Socket Comfort Score (SCS) for sockets, and the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) for AFOs. Workflow time and cost outcomes were also examined. Results: No statistically significant differences were identified between 3D-printed and conventional transtibial sockets across PEQ domains or SCS measures. Of 15 participants contributing preference data, 9 preferred the 3D-printed socket. The digitally enabled socket workflow reduced technician time and total man-hours but increased total cost because of higher consumables costs. In the AFO cohort, overall QUEST scores did not differ significantly between the posterior cut-out MJF AFO and the conventional polypropylene AFO (mean 4.49 vs. 4.55; p = 0.432). Digital fabrication reduced clinician handling time from 60 to 27 min per device. A unilateral MJF AFO design was discontinued because of biomechanical insufficiency. Conclusions: AM demonstrated comparable short-term patient-reported outcomes to conventional fabrication in selected transtibial socket and AFO applications, although the study was not designed to prove clinical equivalence. Operational benefits were conditional and depended on workflow maturity, design suitability, and service context.

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