Original Title: Impresión 3D en traumatología, cardiología, cirugía vascular, cirugía maxilofacial, neurocirugía, lesiones articulares o reparación ósea

Authors' objectives: To gather available evidence on the application of 3D printing technology in various medical disciplines, focusing on its safety, efficacy, economic considerations, and the perspectives of both medical team and patients.

Authors' results and conclusions: A total of 36 studies were included: 25 on safety and efficacy, 13 with economic content (9 exclusively economic and 4 also on safety and efficacy), and 11 on perspectives of the medical team or patients (2 new, 7 also included in efficacy, and 2 in economic). A significant reduction in operative time was observed across multiple body systems, especially the musculoskeletal system. Reductions in intraoperative bleeding and radiation exposure were documented, primarily in the musculoskeletal system, while results for other indications were mixed. Postoperative outcomes were more heterogeneous, with a trend towards reduced hospital stays in some indications. Evidence on postoperative complications and pain was mixed, while postoperative functionality and symmetry/ alignment showed variable results depending on the indication. Economic evidence revealed limited cost-effectiveness data, although production cost data were identified, varying according to the model’s complexity and process stage. Clinicians noted that the technology enhances anatomical understanding and increases confidence during procedures, especially in preoperative planning for complex and high-risk cases. Patients reported a better understanding of their condition and more effective communication with the treatment team. The findings vary depending on the clinical outcome, body system, and indication. Methodological limitations of the studies make it difficult to demonstrate consistent benefits. Clinicians support the contribution of the technology in surgical planning and anatomical guidance, which facilitates the management of complex conditions. The available economic evidence is limited, with a scarcity of cost-effectiveness studies and variable cost data depending on the complexity of the model. The use of 3D printing has been regulated by the European medical device regulations. In Spain, the Real Decreto 192/2023 further specifies the regulation of its use. Conclusive evidence is observed in the reduction of operative time and radiation exposure (mainly in the musculoskeletal system). There is conflicting evidence regarding intraoperative bleeding, intraoperative accuracy, hospital stay, pain, and postoperative function, depending on the system, indication, and age group. It is essential to conduct research that considers clinical challenges, the inherent characteristics of the technology, and its feasibility in the context of medical practice. Implementing prolonged follow-ups is crucial to define clear indications and assess the impact of the technology.

Authors' methods: A review of SR was conducted. The search strategy combined keywords related to 3D printing and its medical applications, applying specific filters to identify SR, MA, and HTA reports in the PubMed, Web of Science, and Scopus databases. The selection process involved screening titles and abstracts by peer reviewers, retrieving full texts, and verifying inclusion criteria, followed by preselection and prioritization based on methodological rigor, clinical relevance, and thematic coverage. The methodological quality was assessed using the AMSTAR 2 tool and Osteba’s Critical Reading Sheets.

Project Status: Completed

Year Published: 2025

URL for published report: https://www.euskadi.eus/contenidos/informacion/osteba_publicacion/eu_def/adjuntos/E-25-10-impresion_3D.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>