ADDITIVE MANUFACTURING OF PROSTHETIC DEVICES: A SCOPING REVIEW OF CLINICAL OUTCOMES

Background

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.

Objective

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. METHODOLOGY: 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.

Results

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.

Conclusion

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. Layman's Abstract Prosthetic limbs help people who have lost a limb, or were born with a limb difference, move and carry out everyday activities. Traditionally, prostheses are manually made using techniques that take time, skill, and clinical resources. 3D printing, which builds an object layer by layer from a digital file, has been suggested as a customizable approach to prosthetic fabrication with possible workflow advantages, though it also carries its own trade-offs. It remains unclear how well 3D-printed prostheses work for the people who use them. This review searched multiple databases to identify published studies examining how people experience 3D-printed prosthetic arms or legs, including how well the devices perform, how comfortable they are, and how satisfied users feel. We identified and reviewed 42 relevant studies, most of which were small reports describing only a handful of patients rather than large trials. In arm prosthesis studies, users often reported improvements in everyday tasks compared to using no prosthesis, though fine motor performance and durability were common weaknesses; results were mixed when compared with conventionally made devices. Studies of leg prostheses generally found comparable outcomes between 3D-printed and conventional devices. Overall, the studies describe 3D-printed prostheses being made, fitted, and used in a range of clinical settings, including custom devices made for specific activities, but the evidence base remains limited. Larger, higher-quality studies with longer follow-up and more consistent outcome measures are needed to better define the role of 3D printing in the production of prostheses.  Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/47836/35342 How To Cite: Bhatla C, Ho M, Devion C, Gao R.Z, Mayo A.L. Additive manufacturing of prosthetic devices: A scoping review of clinical outcomes. Can Prosthet Orthot J. 2026;9(2):5. https://doi.org/10.33137/cpoj.v9i2.47836  Corresponding Author: Dr. Amanda L. Mayo, MD, MHSc, FRCPC, Affiliations: 1) Division of Physical Medicine and Rehabilitation, Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; 2) Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.E-Mail: Amanda.Mayo@sunnybrook.ca ORCID ID: https://orcid.org/0000-0001-7061-2529