Additive manufacturing of prosthetic devices: A scoping review of clinical outcomes

Additive manufacturing (3D printing) has been proposed as a means of improving customization, accessibility, and production efficiency in prosthetic fabrication. However, clinical outcomes remain incompletely characterized, with existing evidence limited by heterogeneous study designs, small samples, and inconsistent outcome reporting.

To conduct a scoping review to map the available evidence on clinical outcomes of 3D-printed prosthetic devices in individuals with limb loss or congenital limb difference.

JBI (formerly Joanna Briggs Institute) methodology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines were followed. MEDLINE, Embase, CINAHL, CENTRAL, and Web of Science were searched from inception to December 31, 2025. Studies were eligible if they reported clinical outcomes, assessed using an identifiable method of measurement, for a functional limb prosthesis directly fabricated using additive manufacturing.

Of 1,396 records screened, 42 studies were included. Thirty-one (73.8%) were case reports or case series; no randomized controlled trials were identified. Thirty-two studies (76.2%) involved upper-limb prostheses and ten (23.8%) involved transtibial devices. Fused deposition modeling (FDM) was the most reported additive manufacturing method (76.2%). In upper-limb studies without a comparator, participants frequently reported improved gross motor function compared with using no prosthesis, while fine motor performance and device durability were common limitations. Where a conventional device was used as a comparator, findings were mixed rather than uniformly favoring either fabrication approach. In lower-limb studies, gait and patient-reported outcomes were generally comparable between 3D-printed and conventionally fabricated devices.

The literature describes 3D-printed prostheses being fabricated, fitted, and used across a range of clinical contexts, including for customized and activity-specific designs, but the evidence base remains limited. Future work should prioritize larger comparative studies, longer follow-up, and more standardized outcome assessment to better define the role of additive manufacturing in prosthetic care.