RESUMO
Objective To investigate the feasibility and primary clinical outcomes of a kind of independent research and development customized 3D printed external fixator in the treatment of tibial fracture.Methods Data of 7 tibial fracture patients who were treated using computer-assisted reduction and 3D printing technique including a new kind of customized external fixator with automatical reduction function from December 2013 to November 2015 were retrospectively analyzed.There were 5 males and 2 females in this cohort.The age of the patients ranged from 25 to 49 years old,with an average age of 38.1 years old.The procedure was as follows.At first,two or three pins were placed separately into the distal and proximal tibia away from fracture site.Then,the CT scanning was performed on the fractured tibia.According to the CT scanning data,the external fixator was designed by computer software and manufactured by the 3D printing technique.The reduction of tibial fracture was achieved automatically after the 3D printed external fixator was connected to the inserted pins.Finally,the accuracy of reduction was assessed by postoperative X-ray image.During the different fracture healing course,the stress environment could be dynamically adjusted by screwing or unscrewing the nuts to fulfill rigid fixation,compression fixation or elastic fixation for the bone healing.Results All the 7 cases had obtained successful reduction by only one time operation with the 3D printed external fixators.The average lateral angulation was 1.42°± 1.13°,and the average anteroposterior angulation was 1.65°± 1.36°,while the average lateral displacement was 1.38± 1.44 mm,and the average anteroposterior displacement was 1.83± 1.30 mm,which were measured from postoperative X-ray image.The individual durations of the operation were 9 min,8 min,9 min,1.5 min,1.4 min,1.4 min and 2.4 min,respectively.All fractures had achieved bony union in 19-25 weeks after operation,with an average time of 21.4±1.6 weeks.All patients were followed up for 6 months when removal of the external fixator,and no refracture occurred.Conclusion The customized 3D printed external fixator has the function of automatical reduction.In addition,it can provide three kinds of fixation modes,which are rigid fixation,compression fixation and elastic fixation.It has the advantages of simple operation,accurate reduction,reasonable fixation,etc.