| OBJECTIVE:up to now, most literature research results showed that using elastic (stable) intramedullary nail (ESIN/EIN) or titanium elastic nail (TEN) to treat diaphyseal fracture of the radius and ulna can obviously improve the total effective rate, but for the rate of the fracture healing and the risk of complications reported clinical results are inconsistent. Therefore, the purpose of this study is to detailedly and comprehensively analysis all randomized controlled trials or quasi-randomized controlled trials of the confirmed cases and accepted the surgical treatment with elastic intramedullary nail, to objectively evaluate the clinical curative effect and security of elastic intramedullary nail and steel plate internal fixation in treatment for double fracture of forearm, clarify it’s benefit in order to provide not only the surgical treatment for clinical decision evidence based medicine which is the highest level, but also the guidance for clinical studies in the future.METHODS:Developed much more solid and complete search strategies, Randomized controlled trials (RCTs) were identified by PubMed (1966～2014.1), EMBASE (1974～2014.1), Cochrane Library (Issue 10,2013), China Biology Medicine/CBM (1978～2014.1), WanFang (1997～2014.1) China National Knowledge Infrastructure/CNKI (1994～2014.1), VIP(1989～ 2014.1), and other electronic databases, "Chinese Journal of Orthopaedics", "Chinese Journal of Orthopaedic Trauma", "The Journal of Pediatric Orthopaedics" et al major Chinese orthopaedic professional journals were searched by manual. With Google internet search engine to find the relevant literature, as well as by multiple pathways to obtain more relevant research literature. RCTs comparing elastic intramedullary nail versus plate fixation in patients with double fracture of forearm, which were collected at home and abroad, were provided by the two researchers independently. In case of any differences in opinions, the two parties shall solve the difference through discussion or turn to a third party. Types of the following observation index to evaluate the clinical efficacy and safety:the total effective rate, X-ray healing time of fracture, hospital stay, infection rate, fractures delay healing, nonunion of fracture, refracture, breakage of internal fixation. According to the Cochrane systematic review to evaluate the quality of the included literature research, and the meta analysis of the results of the included studies was performed using RevMan 5.2 software. Count data use the odds ratio (OR) for curative effect analysis statistics; While measurement data use the mean difference (MD)or the standard mean difference (SMD) if different scales have been used. The effect of both will be expressed in 95% confidence interval (CI).RESULTS:As of January 2014, a total of 7 randomized controlled trials (were all chinese literatures, involving 468 cases) whish had been published were included in this meta-analysis,7 RCT all for comparing the elastic intramedullary nail group versus the steel plate internal fixation group,7 RCT all mentioned random, but did not describe the specific randomized method, the specific allocation concealment method and specific blinding method were also not clear,7 RCT studies were described not lost to follow-up. The results of meta-analyses indicate that:(1) comparing titanium elastic nail group with steel plate internal fixation group, there were statistically significant difference in the total effective rate [OR=5.62,95%CI:(2.42～13.03), P< 0.0001], the time of fracture healing on X-ray [OR=-4.34,95%CI:(5.30～3.39), P< 0.000 01], and the hospitalization time [OR=-4.31,95%CI:(5.48～3.14), P< 0.00001]; (2) In the aspect of the probability of adverse reactions, compared with steel plate internal fixation treatment group, the incidence of refracture and breakage of internal fixation [OR=0.22,95%CI:(0.06～ 0.85), P=0.03、OR=0.09,95%CI:(0.01-0.76), P=0.03] was significantly lower in titanium elastic nail treatment group, But there was no statistically significant difference in infection rate [OR=0.53,95%CI:(0.19～0.48), P=0.23], the incidence of fracture delay healing [OR= 0.52,95%CI:(0.13～2.12), P=0.36], nonunion of fracture [OR=0.52,95%CI:(0.06～ 4.30), P=0.54] between titanium elastic nail group and plate fixation group.CONCLUSION:The actual available and limited supporting evidence indicated that compared with plate fixation, titanium elastic nail to treat diaphyseal fracture of the radius and ulna can significantly improve the total effective rate, shorten the time of fracture healing on X-ray and the hospital stay. At the same time, in the aspect of the security, it also can obviously reduce the incidence of complications, such as refracture and breakage of internal fixation. As a result, the ESIN in repair of diaphyseal fracture of the radius and ulna should be considered as a reliable and effective clinical treatment method, it is worthy of being widely popularized in clinical application. In addition, the methodological qualities of the studies included in this systematic review were general poor, the sample size is small, the design methods of some studies were not strictly. Therefore, it will be necessary to need more reasonable design, correct methods, high quality, large samples, multi-centered randomized controlled trial to further verify the conclusion in the clinical practice in the future. |
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