超声骨强度仪测定人体跟骨骨强度的有效性和安全性研究

Effectiveness and Safety of Quantitative Ultrasound Device Used for Measuring Calcaneal Bone Strength Index of Human Subjects

目的评价超声骨强度仪测定人体跟骨骨强度的临床有效性和安全性。方法150名受试者(20~80岁)先后使用试验器械(型号规格:Oste-scan 500A)和对照器械(型号规格:SONOST3000)测定同一跟骨骨强度;评价骨密度诊断的一致率、检测参数的准确性和产品使用性能,记录生命体征、不良事件和器械缺陷。结果试验器械和对照器械骨密度诊断结果一致,检测参数差异均无统计学意义(P>0.05),器械功能正常;未发生不良事件,无器械缺陷。结论试验器械用于测量成人跟骨骨强度指数安全、有效,满足临床要求。

Objective To examine whether a quantitative ultrasound(QUS)device(Oste-scan 500A)is effective and safe in measuring calcaneal bone strength index of human subjects.Methods 150 participants(20~80 years of age)had the same calcaneal bone strength measured using a test device(model size:Oste-scan 500A)and a control device(model size:SONOST3000).The consistency of bone density diagnosis,accuracy of test parameters and product performance were evaluated and vital signs,adverse events and device defects were recorded.Results Bone density diagnostic results were consistent between the test and control devices,with no statistically significant differences in any of the tested parameters and normal device function.No adverse events and device defects occurred.Conclusions The test device is safe,effective and meets the clinical requirements to measure calcaneal bone strength index of human subjects.