Riassunto dello studio

Two-hundred and forty patients were randomized to receive intramedullary nailing or external fixation. The primary outcomes included incidence of re-operation for deep infection, non-union, and malalignment as well as the incidence of mortality. Secondary outcomes included quality of life through using EuroQol-5 Dimensions, 3 level questionnaire (EQ-5D-3L) and EQ-Visual Analog Scale (VAS), radiographic alignment, and healing. The EQ-5D-3L and EQ-VAS questionnaire data were collected at 2, 6, 12, 26, and 52 weeks. Radiographic healing was measured through the modified Radiographic Union Scale for Tibial fractures (mRUST) questionnaire in which data were collected at 6, 12, 26, and 52 weeks. Significant differences were not observed for the primary outcomes. However, coronal malalignment improved within the intramedullary nailing treatment group. Furthermore, quality of life as measured by EQ-5D-3L and EQ-VAS, improved at 6 weeks which did not continue through to the 1-year follow-up. Yet, radiographic fracture healing improved both at 6 and 12 weeks as well as 1-year follow-up.