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.

This sub-analysis of the PROPER study aimed to evaluate outcomes following the transition from reference adalimumab (ADL) to SB5 (Imraldi™) in routine clinical practice in Spanish patients with rheumatoid arthritis (RA). Adult Spanish patients (n = 73) with RA who initiated SB5 as part of routine clinical practice following treatment with reference ADL were recruited. Outcome measures included persistence on SB5, clinical characteristics, and disease activity scores at the time of transition to SB5 treatment, clinical management over time, and safety. At Week 48, the Kaplan-Meier [95% confidence interval (CI)] estimate of the probability of persistence on SB5 after switching from reference ADL was 0.84 (0.73–0.90) and 83.6% (46/55) of patients were in remission or had low disease activity. The majority of patients [83.6% (61/73)] experienced no disease flare during the study period and reported that the injection was “simple or very simple” to administer (baseline: 66.7%; Week 48: 69.0%) and were generally “satisfied or very satisfied” with the duration of the injection. In total, 21 patients (21/73, 28.8%) reported at least one drug-related adverse event, which were mild in most cases (17/21, 80.9%). In a Spanish cohort of patients with RA transitioning from reference ADL to SB5, the probability of SB5 persistence was high and treatment effectiveness was maintained for up to 48 weeks. There were no new safety signals and SB5 was well tolerated. These findings suggest that there is no evidence to mitigate against transition from reference ADL to SB5 in patients with RA (Clinicaltrials.gov listing: NCT04089514).

Aim: The use of anti-TNF drugs is well-established for treating axial spondyloarthritis (axSpA). The introduction of biosimilars offers a more accessible alternative, but data on the switching of adalimumab biosimilars in the axSpA population remain somewhat controversial and are limited to SB5 and ABP 501 and to the European population. This study aims to evaluate the clinical efficacy of switching from originator adalimumab to the biosimilar adalimumab-AACF in Latin American axSpA patients over a 12-month period in a real-life analysis. Methods: This observational study included patients with axSpA who had been treated with originator adalimumab for at least three months and switched to the biosimilar. Disease activity parameters and C-reactive protein (CRP) levels were assessed at baseline (T0) and compared at 6 (T6) and 12 months (T12) following the switch. Results: Twenty-eight patients were included, with a mean duration of originator adalimumab use of 87.6 months. Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP remained stable when comparing T0 to T6 [1.56 (± 0.88) vs. 1.50 (± 0.82), P = 0.73] and T12 [1.56 (± 0.88) vs. 1.26 (± 0.86), P = 0.13]. A similar pattern was observed for ASDAS-erythrocyte sedimentation rate (ESR; P > 0.05) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; P > 0.05). The rate of remission/low disease activity was consistent, recorded at 71.4% at baseline, 78.6% at T6 (P = 0.62) and 78.6% at T12 (P = 0.68). CRP levels did not show significant variation (P > 0.05) across time points. Notably, the one-year drug retention rate was 94.6%. Conclusions: This real-world study highlights for the first time the feasibility and efficacy of transitioning from originator adalimumab to biosimilar AACF in axSpA, providing support for its use in long-term management and offering enhanced accessibility without compromising therapeutic outcomes. These results add valuable Latin American data to the body of evidence on biosimilar integration into clinical practice.