3D打印辅助微创接骨板内固定术(MIPO)改善胫骨旋转不良的前瞻性随机对照研究

目的 比较微创接骨板内固定术（MIPO）、髓内钉内固定术（INT）和3D打印辅助MIPO 3种内固定技术治疗胫骨骨折后胫骨旋转不良的程度和发生率。方法 纳入上海中医药大学附属曙光医院于2015年1月至2017年8月收治的180例单侧胫骨骨折患者（年龄16~60岁），不论分型按入组先后顺序依次分入MIPO组、INT组和3D打印辅助MIPO（3D-MIPO）组，每组60例，平均年龄分别为（39.18±9.10）、（39.28±9.23）和（39.07±10.40）岁。术后CT扫描双侧膝、踝关节层面，测量患侧和健侧旋转角并计算其差值，其差值绝对值>10°定义为胫骨旋转不良。比较并分析3组患者在治疗胫骨骨折后胫骨旋转不良的程度和发生率。结果 3组患者的性别、年龄、骨折分型差异均无统计学意义。3组患者术后均恢复顺利，无感染、内固定松动等发生，个别患者伤口出现渗液经换药或清创后愈合。MIPO组旋转角平均差值为（6.85±3.82）°，其中内旋9例、外旋51例，确诊胫骨旋转不良7例，发生率为11.67%；INT组旋转角平均差值为（6.34±3.44）°，其中内旋10例、外旋50例，确诊胫骨旋转不良6例，发生率为10.00%；3D-MIPO组旋转角平均差值为（3.96±2.24）°，其中内旋8例、外旋52例，确诊胫骨旋转不良1例，发生率为1.67%。3组旋转角平均差值差异有统计学意义（F=13.80，P<0.01），3D-MIPO组胫骨旋转不良发生率低于MIPO组和INT组，差异均有统计学意义（P均<0.05）。结论 利用3D打印辅助完成术前钢板塑形可降低MIPO后胫骨旋转不良的发生率。
Objective To compare the severity and incidence of tibial malrotation after treatment with minimally invasive plate osteosynthesis (MIPO), intramedullary nail technique (INT) and 3D printing auxiliary MIPO (3D-MIPO) for tibial fracture patients. Methods A total of 180 unilateral tibial fracture patients aged 16 to 60 years were enrolled from Shuguang Hospital of Shanghai University of Traditional Chinese Medicine between Jan. 2015 and Aug. 2017. Without consideration of the fracture classification, the patients were divided into MIPO group, INT group and 3D-MIPO group according to the order of the patients entering the study, with 60 cases in each group. The average ages of the patients in the MIPO, INT and 3D-MIPO groups were (39.18±9.10), (39.28±9.23) and (39.07±10.40) years old, respectively. Post-operative CT scanning was carried out at bilateral knee and ankle joint levels, and the differences of rotation angles between the affected side and the healthy side were measured and calculated. The absolute value of the difference that was greater than 10° was defined as malrotation. The severity and incidence of tibial malrotation were compared among the three groups. Results The MIPO, INT and 3D-MIPO groups had no significant differences in the gender, age, or fracture type. All the cases recovered smoothly without infection or loosening of internal fixation, and the wound exudation in individual patients was healed after dressing change. Mean difference value of rotation angle of the MIPO group was (6.85±3.82)°; 9 cases had internal rotation and 51 had external rotation; and 7 (11.67%) cases were diagnosed as tibial malrotation. The mean difference value of the INT group was (6.34±3.44)°, 10 internal and 50 external rotation, 6 (10.00%) tibial malrotation. And the mean difference value of the 3D-MIPO group was (3.96±2.24)°, including 8 internal and