通过前瞻性临床研究，将膝关节骨性关节炎（KOA）患者作为研究对象，比较了国产3D打印矫形鞋垫和药物保守治疗对不同程度 KOA 患者的疗效和预后，指标包括胫骨内翻角（TBVA）、膝关节活动度（ROM）、国际膝关节文献委员会（IKDC）主观评分、疼痛视觉模拟评分（VAS）、临床有效率及膝关节损伤和骨关节炎评分（KOOS）。结果显示，矫形组的 TBVA、KOOS-症状、KOOS-日常活动及KOOS-生活质量均显著小于服药组，而IKDC评分显著高于服药组，对于中度KOA患者，矫形组的ROM及临床有效率显著高于服药组。说明国产3D打印矫形鞋垫治疗中重度KOA的疗效及预后优于药物保守治疗，且其对中度KOA患者的疗效更佳。
Knee osteoarthritis (KOA) is the most common disease of the sports system, with a high disability rate, and is an urgent public health problem in China at present. Through a prospective clinical study, this study took KOA patients as the research objects, and aimed to compare the efficacy and recovery of domestic 3D printed orthopedic insoles and drug conservative treatment for different degrees of KOA patients. Indicators included the tibial varus angle (TBVA), knee joint range of motion (ROM), subjective score of the International Knee Joint Literature Committee (IKDC), pain visual simulation score (VAS), and clinical effectiveness, Knee joint injury and osteoarthritis score (KOOS). The results showed that the TBVA, KOOS-symptoms, KOOS-activities of daily living, and KOOS-quality of life in the orthopedic group were significantly lower than those in the medication group, while the IKDC score was significantly higher than those in the medication group. For patients with moderate KOA, the ROM and clinical effective rate in the orthopedic group were significantly higher than those in the medication group. It showed that the efficacy and prognosis of domestic 3D printed orthopedic insoles in the treatment of moderate and severe KOA were better than that of drug conservative treatment, and its efficacy was better for patients with moderate KOA.
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