Abstract:[Objective] To compare the clinical efficacy of unilateral external fixator versus intramedullary nail for spiral tibial shaft fractures. [Methods] A retrospective study was done on 64 patients who had surgical treatment for spiral tibial shaft fractures in our hospi- tal from June 2015 to December 2020. According to the results of preoperative doctor-patient communication, 32 patients had the fractures fixed with unilateral external fixator (the EF group), while the other 32 patients were fixed with intramedullary nail (the IN group). The peri- operative period, follow-up and imaging data were compared between the two groups. [Results] All the 64 patients were successfully operat- ed on without serious complications. The EF group proved significantly superior to the IN group in terms of operative time, incision length, intraoperative blood loss, postoperative walking time and hospital stay (P<0.05), despite of no significant difference in the number of intra- operative fluoroscopy between the two groups (P>0.05). All the 64 patients were followed up for more than 12 months, and the EF group re- sumed full weight-bearing activity of the affected limb significantly earlier than the IN group (P<0.05). The VAS scores decreased signifi- cantly (P<0.05), while the AOFAS score and ankle plantar-dorsiflexion range of motion (ROM) increased significantly in both groups over time (P<0.05). At any corresponding time points there were no significant differences in AOFAS score and ROM between the two groups (P> 0.05). The EF group was marked significantly higher VAS score than the IN group 3 months after surgery (P<0.05), whereas which became not significant different between the two groups at the latest follow-up (P>0.05). Radiographically, there were no significant differences in the quality of fracture reduction and fracture healing time between the two groups (P>0.05). [Conclusion] Both unilateral external fixator and intramedullary nail do achieve good clinical outcomes for spiral tibial shaft fractures. In comparison, unilateral external fixator is less invasive and allows patients to actively move early.