Three-dimensional printed upper-limb prostheses lack randomised controlled trials: A systematic review

Laura E Diment, Mark S Thompson, Jeroen Hm Bergmann, Laura E Diment, Mark S Thompson, Jeroen Hm Bergmann

Abstract

Background: Three-dimensional printing provides an exciting opportunity to customise upper-limb prostheses.

Objective: This review summarises the research that assesses the efficacy and effectiveness of three-dimensional printed upper-limb prostheses.

Study design: Systematic review.

Methods: PubMed, Web of Science and OVID were systematically searched for studies that reported human trials of three-dimensional printed upper-limb prostheses. The studies matching the language, peer-review and relevance criteria were ranked by level of evidence and critically appraised using the Downs and Black Quality Index.

Results: After removing duplicates, 321 records were identified. Eight papers met the inclusion criteria. No studies used controls; five were case studies and three were small case-series studies. All studies showed promising results, but none demonstrated external validity, avoidance of bias or statistically significant improvements over conventional prostheses. The studies demonstrated proof-of-concept rather than assessing efficacy, and the devices were designed to prioritise reduction of manufacturing costs, not customisability for comfort and function.

Conclusion: The potential of three-dimensional printing for individual customisation has yet to be fully realised, and the efficacy and effectiveness to be rigorously assessed. Until randomised controlled trials with follow-up are performed, the comfort, functionality, durability and long-term effects on quality of life remain unknown. Clinical relevance Initial studies suggest that three-dimensional printing shows promise for customising low-cost upper-limb prosthetics. However, the efficacy and effectiveness of these devices have yet to be rigorously assessed. Until randomised controlled trials with follow-up are performed, the comfort, functionality, durability and long-term effects on patient quality of life remain unknown.

Keywords: Computer-aided design–computer-aided manufacturing; children’s prosthetics; evaluation studies; prosthetic design; rapid prototyping; study design; upper-limb prosthetics.

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

Figures

Figure 1.
Figure 1.
Flow chart of the selection and sorting method.

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Source: PubMed

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