METHODS: The EOSedge™ system is a digital radiography system that delivers whole-body, high-quality 2D/3D biplanar images covering the complete set of musculoskeletal and orthopedic exams. Full HTA model was chosen using the EUnetHTA Core Model® version 3.0. The HTA Core Model organizes the information into nine domains. Information was researched and obtained by consulting the manufacturers\' user manuals, scientific literature, and institutional sites for regulatory aspects.
RESULTS: All nine domains of the EUnetHTA Core Model® helped conduct the HTA of the EOSedge, including (1) description and technical characteristics of the technology; (2) health problem and current clinical practice; (3) safety; (4) clinical effectiveness; (5) organizational aspects; (6) economic evaluation; (7) impact on the patient; (8) ethical aspects; and (9) legal aspects.
CONCLUSIONS: EOS technologies may be a viable alternative to conventional radiographs. EOSedge has the same intended use and similar indications for use, technological characteristics, and operation principles as the EOS System and provides significant dose reduction factors for whole spine imaging compared to the EOS System without compromising image quality. Regarding the impact of EOS imaging on patient outcomes, most studies aim to establish technical ability without evaluating their ability to improve patient outcomes; thus, more studies on this aspect are warranted.
方法:EOSedge™系统是一种数字射线照相系统,可提供全身,高质量的2D/3D双平面图像,涵盖全套的肌肉骨骼和骨科检查。使用EUnetHTACoreModel®3.0版选择了完整的HTA模型。HTA核心模型将信息组织成九个域。通过查阅制造商的用户手册来研究和获得信息,科学文献,和监管方面的机构网站。
结果:EUnetHTACoreModel®的所有九个领域都帮助进行了EOSedge的HTA,包括(1)技术的描述和技术特征;(2)健康问题和当前临床实践;(3)安全性;(4)临床有效性;(5)组织方面;(6)经济评估;(7)对患者的影响;(8)道德方面;(9)法律方面。
结论:EOS技术可能是常规射线照相的可行替代方案。EOSedge具有相同的预期用途和类似的使用适应症,技术特点,和操作原理作为EOS系统,与EOS系统相比,为整个脊柱成像提供了显着的剂量减少因子,而不会影响图像质量。关于EOS成像对患者预后的影响,大多数研究旨在建立技术能力,而不评估其改善患者预后的能力;因此,有必要对这方面进行更多的研究。