Abstract
BACKGROUND: External fixators (EFs) and intramedullary nailing (IMN) are two effective methods for open tibial fractures. However, both methods have advantages and disadvantages, and the optimal surgical approach remains controversial. Thus, we performed a meta-analysis of randomized controlled trials (RCTs) to compare EF with IMN to evaluate their efficacy and safety. METHODS: A systematic study of the literature was conducted in relevant studies published in PubMed, Embase, the Cochrane Library, Web of Science, CNKI, CBM, Wanfang and Weipu from database inception to April 2022. All eligible literature was critically appraised for methodological quality via the Cochrane's collaboration tool. The primary outcome measurements included postoperative superficial infection, postoperative deep infection, union time, delayed union, malunion, nonunion, and hardware failure. RESULTS: Nine RCTs involving 733 cases were included in the current meta-analysis. The pooled results suggested that cases in the IMN group had a significantly lower postoperative superficial infection rate [risk ratio (RR) = 2.84; 95% confidence interval (CI) = 1.83 to 4.39; P < 0.00001)] and malunion rate (RR = 3.05; 95% CI = 2.06 to 4.52; P < 0.00001) versus EF, but IMN had a significantly higher hardware failure occurrence versus EF (RR = 0.38; 95% CI = 0.17 to 0.83; P = 0.02). There were no significant differences in the postoperative deep infection rate, union time, delayed union rate or nonunion rate between the two groups (p > 0.05). CONCLUSIONS: Compared to EF, IMN had a significantly lower risk of postoperative superficial infection and malunion in patients with open tibial fractures. Meanwhile, IMN did not prolong the union time and increased the risk of the deep infection rate, delayed union rate and nonunion rate but had a higher hardware failure rate. The reanalysis of union time showed that it was significantly shorter in the IMN group than in the EF group after excluding the study with significant heterogeneity during sensitivity analysis. Therefore, IMN is recommended as a preferred method of fracture fixation for patients with open tibial fractures, but more attention should be given to the problem of hardware failure.