Improve the Efficiency of Surgery for Femoral Shaft Fractures with A Novel Instrument: A Randomized Controlled Trial

OBJECTIVE To improve the efficacy of closed reduction and wire guiding during intramedullary nail internal fixation in femoral shaft fractures. METHODS A novel instrument was designed and manufactured. Sixty-eight patients were enrolled from February 2011 to December 2013. The instrument designed was used during the operation in the experimental group, but not in the control group. RESULTS All patients exhibited fracture union, excluding 1 patient in the experimental group and 2 in the control group who had non-union; all of whom achieved fracture union with reoperation. There were no statistically significant differences in operative blood loss or duration of hospital stay between the groups (P > 0.05). The operative time, frequency of wire drilling, and number of open reduction cases, were significantly smaller in the experimental group than in the control group (P < 0.05). CONCLUSION Femoral shaft fractures are difficult to reduce using general methods; the novel instrument showed high clinical value and proved effective and safe in assisting with closed reduction and intramedullary nail fixation for femoral shaft fractures. TRIAL REGISTRATION ChiCTR ChiCTR-ICR-15007335.