A novel dynamic electromagnetic tracking navigation system for distal locking of intramedullary nails.

Background: The accurate distal locking of intramedullary (IM) nails is a clinical challenge for surgeons. Although many navigation systems have been developed, a real-time guide method with free radiation exposure, better user convenience, and high cost performance has not been proposed.

Methods: This paper aims to develop an electromagnetic navigation system named TianXuan-MDTS that provides surgeons with a proven surgical solution. And the registration method with external landmarks for IM nails and calibration algorithm for guiders were proposed. A puncture experiment, model experiments measured by 3D Slicer and cadaver experiments (2 cadaveric leg specimens and 6 drilling operations) are conducted to evaluate its performance and stability.

Results: The registration deviations (TRE) is 1.05± 0.13 mm. In the puncture experiment, a success rate of 96% can be achieved in 45.94 s. TianXuan-MDTS were evaluated on 3 tibia model. The results demonstrated that all 9 screw holes were successfully prepared at a rate of 100% in 91.67 s. And the entry point, end point, and angular deviations were 1.60±0.20 mm, 1.47±0.18 mm, and 3.10±0.84°, respectively. Postoperative fluoroscopy in cadaver experiments showed that all drills were in the distal locking holes, with a success rate of 100% and the average time 143.17± 18.27 s.

Conclusions: The experimental results indicate that our system with novel registration and calibration methods could serve as a feasible and promising tool to assist surgeons during distal locking.