Navigation in femoral-shaft fractures--from lab tests to clinical routine.

INTRODUCTION This study evaluates the use of a navigation system (BrainLAB, Feldkirchen, Germany) to intra-operatively check for correct length, axis and rotation in intramedullary nailing of femoral-shaft fractures in an experimental setting and in clinical routine. MATERIALS AND METHODS We tested the navigation system in two experimental settings before introducing it into clinical routine. In the first experiment, 10 osteotomised model femora were fixed with intramedullary nails by using a navigation system. The goal was a locking fixation in predefined values for length and rotation. In the second experiment, eight examiners assessed values for rotation and length of one femur 10 times to examine the accuracy and reproducibility of that determination. Following this, we navigated 40 femoral nailing procedures in our department. Preoperatively, we assessed values of femur geometry on the contralateral side in a computed tomography (CT) scan and reproduced these values intra-operatively on the fractured side, guided by the navigation system. During the intervention, we recorded the length of the procedure steps and the fluoroscopy time. We verified the intra-operative values achieved with the navigation system in a postoperative CT scan and documented differences in rotation and length. After the assessment, we analysed the data for different findings on femur geometry, fluoroscopy time and procedure duration. RESULTS The experimental evaluation showed a range of ±5° for anteversion differences and ±2.3 mm for length differences. We estimated this accuracy as sufficient to use the system in clinical routine. The navigation system was used for 40 fracture fixations. All our criteria for restoring femoral geometry could be achieved by navigation guidance in these procedures. Setting up the system took on average 33±11.5 min. An additional fluoroscopy time of 36±22 s was needed to acquire the reference X-rays and to verify pin placement. The differences between anteversion values assessed in intra-operative planning steps on the navigation system and values assessed with a postoperative CT were on average 5.4±3.5°, whilst femur length differed on average by 4±4 mm. DISCUSSION Many authors judge intra-operative control of anteversion in femoral-shaft fracture fixation as problematic. Neither our experimental navigation assessment nor our clinical navigated evaluation showed relevant anteversion differences to a postoperative CT assessment of femur geometry. After initial training, guidance by a navigation system achieves consistent results in a clinical situation. CONCLUSIONS The use of a navigation system to align axis, length and rotation led to a secure way of avoiding any relevant malalignment in complex femur-shaft fractures whilst exposing patients to an acceptable amount of additional procedure sequences. Malalignment can be avoided by using a navigation system in the operative treatment of femoral-shaft fractures and may be integrated into clinical routine in specialised centres.