Background: Mandibular distraction osteogenesis (MDO) is critical for correcting mandibular hypoplasia. Mixed reality (MR) is an emerging surgical-navigation technology that can overcome the limitations of traditional methods. However, evidence regarding the benefits of MR navigation in MDO is limited. Herein, we developed a dynamic MR-based navigation system and compared its performance to techniques using surgical guides (SGs) as well as freehand (FH) and traditional navigation (TN) approaches.
Methods: An adjacent-display MR navigation system integrating optical tracking and a patient-specific registration device was developed for real-time dynamic guidance. Thirty mandibular three-dimensional (3D)-printed models were allocated to three groups (n = 10 each): MR, SG, and FH. Thirty-two Beagle dogs were randomised into four groups (n = 8 each): MR, SG, FH, and TN. The feasibility of the MR system was evaluated in 10 human cadaver heads. All procedures were performed by the same surgical team. The outcomes included osteotomy accuracy, distraction-vector deviation, distractor placement precision, intraoperative corrections, and operative time.
Results: In the model experiments, the MR group showed significantly higher distractor and osteotomy accuracy than the FH group and similar precision as the SG group. In animal studies, the MR approach reduced errors in distractor placement, distraction vector, and osteotomy in comparison with the FH approach, and outperformed the SG-based approach in terms of distractor positioning and osteotomy accuracy. In comparison with TN, the MR approach excelled in distractor positioning, osteotomy accuracy, and reduced operative time. Cadaver experiments revealed sagittal and transverse distractor errors of 1.99° ± 0.67° and 1.63° ± 0.88°, respectively, distraction-vector deviation of 2.62° ± 0.38°, and osteotomy angle deviation of 1.74° ± 0.50°. The average operative time was 85.23 ± 13.04 min; distractor positioning required 54.08 ± 15.71 min and the number of intraoperative corrections was 6.80 ± 1.87.
Conclusions: The dynamic MR navigation system achieved better accuracy than the FH approach and showed specific advantages over the TN and SG-based approaches, indicating its potential clinical applicability for precise MDO.
Trial registration: This study was registered with the Chinese Clinical Trial Registry (ChiCTR2500098863).
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