Computer-assisted navigation for intramedullary nail fixation of intertrochanteric femur fractures: A randomized, controlled trial.

ABSTRACT

INTRODUCTION: Lag screw cutout is one of the most commonly reported complications following intramedullary nail fixation of intertrochanteric femur fractures. However, its occurrence can be minimized by a well-positioned implant, with a short Tip-to-Apex Distance (TAD). Computer-assisted navigation systems provide surgeons with the ability to track screw placement in real-time. This could allow for improved lag screw placement and potentially reduce radiation exposure to the patient and surgeon. METHODS: Between Oct 2014 and Jan 2016, patients with intertrochanteric femur fractures being treated with intramedullary nail fixation by one of three fellowship-trained orthopaedic traumatologists were enrolled. Inclusion criteria were low-energy mechanism of injury and fracture class 31-A1/A2. Open fractures and patients with multiple injuries to the lower extremity were excluded. Patients were randomly assigned to computer-assisted navigation or a conventional fluoroscopic technique for lag screw placement. The primary outcomes were TAD, measured by postoperative anteroposterior and lateral x-rays by an independent reviewer, and radiation exposure measured in seconds of fluoroscopy time. Surgical time was also recorded. RESULTS: 50 patients were randomized, 26 to the computer-assisted navigation group and 24 to the control group. The mean manually-measured TAD in the computer-assisted navigation group was 14.1mm±3.2 and in the control group was 14.9mm±3.0 (p=0.394). There was no difference between groups in total radiation time (navigation 58.8 s±23.6, control 56.5 s±28.5, p=0.337) or radiation time during lag screw placement (navigation 19.4 s±8.8, control 18.8 s±8.0, p=0.522). The surgical time was significantly longer in the computer-assisted navigation group with a mean surgical time of 45.8min±9.8 compared to 38.4min±9.3 in the control group (p=0.009). CONCLUSIONS: Computer-assisted navigation consistently produced excellent TADs, however it was not significantly better than conventional methods when done by fellowship-trained orthopaedic traumatologists. Surgeons with a lower volume trauma practice could potentially benefit from computer-assisted navigation to obtain better TAD.