Quality approaches and standards of 3D printing in orthopedic and traumatological settings: a systematic review

Abstract

Background: The ongoing digital transformation of healthcare has enabled innovative technologies that improve diagnosis, treatment planning, and outcomes. Among these, three-dimensional (3D) printing has gained prominence in surgical disciplines for converting digital imaging data into patient-specific physical models. In orthopedics and traumatology, 3D printing is used to produce anatomical models, surgical guides, and custom implants, thereby enhancing preoperative planning, surgical precision, and interdisciplinary communication. Despite its growing adoption, integrating 3D printing into clinical workflows remains complex and requires stringent quality assurance. Each phase of the production process-from image acquisition and segmentation to material selection and post-processing-affects the safety and performance of the final product. Standardized quality approaches and regulatory frameworks are therefore essential to ensure reproducibility, biocompatibility, and patient safety. This systematic review consolidates current knowledge on quality standards and implementation strategies for 3D printing in orthopedic and traumatological care. It identifies practical pathways for clinical integration while highlighting challenges, opportunities, and areas for future research.

Methods: A systematic literature search was conducted in PubMed, the Cochrane Library, and the Web of Science, following the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) 2015 checklist and supplemented by manual searches. Reference management was performed using Rayyan QCRI (Qatar Computing Research Institute). Abstracts and full texts were analyzed with Voyant Tools to identify thematic focuses based on collocate analysis.

Results: Nineteen publications met the inclusion criteria. The review highlights a focused but limited body of literature. Key factors influencing product quality include material choice, manufacturing accuracy, and adherence to validated quality control protocols.

Discussion: With increasing digitalization and the integration of artificial intelligence, future quality initiatives will likely emphasize standardized preoperative planning, ethical oversight, and regulatory compliance to support personalized care models in orthopedics and traumatology.

Keywords

Three-dimensional printing / orthopedics / traumatology / quality / quality indicators / process

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