Intramedullary nail versus bridge plate in open tibial fractures - randomized clinical trial

Introduction Open tibial shaft fractures present a challenge to the orthopedic surgeon, because they are common, have a high rate of complications and still have a controversial treatment. As a result of the high incidence of these fractures, the need of a definitive treatment and the unavailability of the intramedullary nail or a well-trained team, we developed this study to compare the effectiveness of the bridge-plating (BP) with the unreamed intramedullary nail (UIMN) in the treatment of open tibial shaft fractures. Materials and methods Eighty patients were included in a prospective, consecutive and random way and then randomized in two groups of treatment: unreamed intramedullary nail and bridge-plating. The primary outcomes were the reoperation rate and the Johner-Wruhs functional criteria. Secondary outcomes were complication rates, partial and total weight bearing time and bone consolidation time. We verified the existence of normality in the quantitative variables for the outcomes using the Kolmogorov-Smirnov test. The Chi-Square test was utilized to compare the methods according to the relative frequencies and the comparison between the methods regarding the average of the quantitative variables was done through the T-Student test. Results Both the reoperation rates and the functional criteria of Johner-Wruhs showed no difference between the two groups. The exposure time and the total surgical time were longer in the UIMN group, however the consolidation time, partial weight bearing time and total weight bearing time did not show significant difference. A significant difference was found between the groups in the implant failure rate, in favor of UIMN, the angular malalignment was another secundary outcome that showed a non significant difference in favor of UIMN. Conclusions We concluded that both methods were effective for the treatment of open tibia shaft fractures, however, the implant failure rate was higher in the bridge plate group.