Atallah Huthaifa, Qufabz Titeana, Bakhsh Hadeel R, Ferriero Giorgio
Prosthetics and Orthotics Department, School of Rehabilitation Sciences, The University of Jordan, Amman, 11942, Jordan.
Department of Rehabilitation sciences, College of health and Rehabilitation sciences, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.
BMC Musculoskelet Disord. 2025 Sep 1;26(1):822. doi: 10.1186/s12891-025-09070-4.
3D-printing is an emerging technology that is used in the manufacturing of orthotic devices. 3D-printing has many advantages such as improved fit, comfort, effectiveness, and patient satisfaction. While some challenges like durability and material selection remain, the aim of this systematic review is to provide a comprehensive evaluation of the clinical outcomes of 3D-printed orthoses.
A search was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines across six databases (PubMed, Web of Science, EBSCO, Scopus, Cochrane Library, and Sage). Studies on 3D-printed orthoses in human rehabilitation that focused on the clinical outcomes of the device were included. While studies lacking clinical data, 3D-printing details, or focusing on traditional manufacturing methods were excluded. Finally, the risk of bias was assessed using the modified Downs & Black Checklist.
A total of 1279 studies were identified, with 62 meeting the inclusion criteria. The included studies assessed different 3D-printed orthotic types, including insoles, ankle foot orthoses (AFOs), spinal orthoses, upper-limb orthoses, and helmets. The main clinical outcomes that were analyzed are gait parameters, functional performance, radiographic measurements, comfort, fit, and effectiveness. Studies on 3D-printed insoles demonstrated effective plantar pressure redistribution, and increased comfort. While studies on 3D-printed AFOs showed improvements in gait symmetry and mobility. 3D-printed spinal orthotics showed reductions in Cobb angles and enhanced postural stability in scoliotic patients. While 3D-printed upper-limb orthoses found improved grip strength, spasticity management, and user satisfaction. Finally, studies on 3D-printed helmets for cranial deformities demonstrated improved fit and reduced treatment duration.
3D-printed orthoses can enhance gait parameters, functional performance, comfort, fit, and effectiveness, compared to conventional methods. However, limitations such as small sample sizes, lack of standardized assessment methods, and durability concerns must be addressed through further research.
3D打印是一项新兴技术，用于制造矫形器械。3D打印具有许多优点，如贴合度提高、舒适度增加、效果更好以及患者满意度提升。虽然仍存在一些挑战，如耐用性和材料选择，但本系统评价的目的是对3D打印矫形器的临床结果进行全面评估。
按照系统评价和Meta分析的首选报告项目（PRISMA）指南，在六个数据库（PubMed、科学网、EBSCO、Scopus、Cochrane图书馆和Sage）中进行检索。纳入关注3D打印矫形器在人体康复中临床结果的研究。排除缺乏临床数据、3D打印细节或关注传统制造方法的研究。最后，使用改良的唐斯&布莱克清单评估偏倚风险。
共识别出1279项研究，其中62项符合纳入标准。纳入的研究评估了不同类型的3D打印矫形器，包括鞋垫、踝足矫形器（AFO）、脊柱矫形器、上肢矫形器和头盔。分析的主要临床结果包括步态参数、功能表现、影像学测量、舒适度、贴合度和效果。关于3D打印鞋垫的研究表明，其能有效重新分配足底压力并提高舒适度。关于3D打印AFO的研究显示，步态对称性和活动能力有所改善。3D打印脊柱矫形器在脊柱侧弯患者中显示出Cobb角减小和姿势稳定性增强。而3D打印上肢矫形器则显示握力提高、痉挛管理改善以及用户满意度提升。最后，关于用于颅骨畸形的3D打印头盔的研究表明，贴合度提高且治疗时间缩短。
与传统方法相比，3D打印矫形器可改善步态参数、功能表现、舒适度、贴合度和效果。然而，诸如样本量小、缺乏标准化评估方法以及耐用性问题等局限性必须通过进一步研究加以解决。
