Cannulated screw fixation is essential in treating femoral neck fractures, and the widely used freehand technique has several limitations. Therefore, we designed a new laser-positioning and navigation system and compared its efficacy with that of the traditional freehand technique in the cannulated screw fixation of femoral neck fractures. This randomized controlled single-blind trial recruited patients with femoral neck fracture, who were treated using either the newly designed laser-navigation device or the freehand technique. In in-vitro experiments, using the femoral neck model, the laser group was better than the freehand group in terms of operation time (P=0.0153) and radiation exposure time (P<0.001). In in-vivoexperiments, involving 30 patients (15 in each group), the laser group was better than the freehand group in terms of operation time (P<0.001), radiation exposure time (P<0.001), blood loss (P<0.001) and first success rate (P=0.03). There was no difference in visual analog scale score, Harris score, and fracture-healing time between the two groups. In conclusion, the novel laser-guiding navigation system resulted in shorter operation time, less radiation exposure, and higher first success rate compared with the freehand technique. Further qualified investigations with a larger number of patients and longer follow-up are required in the future.