An Alternative Internal Le Fort I Distractor: Early Results With a New Trans-Nasal Device.

Purpose: To report the early experience using a new internal trans-nasal Le Fort I distractor in patients with cleft lip and palate.
Methods: Patients with cleft lip and palate and severe maxillary deficiency, who were treated with the trans-nasal Le Fort I distractor, were retrospectively reviewed. Cephalometric images were evaluated preoperatively and at least 6 months postoperatively. Speech outcomes were measured before and at least 6 months after surgery. Patient experience with the device was documented and complications were recorded.
Results: Five male patients with bilateral cleft lip and palate (ages 11-19) underwent the maximum advancement allowed by the device (25 mm). Follow-up averaged 2 years. Average SNA changed from 75.5°preoperatively to 84.6°postoperatively. Average ANB angle changed from -2.8° to 7.4°, or a tendency to Class 2 overcorrection. There was an overall increase in upper anterior facial height by 7.5 mm. All patients achieved acceptable postoperative occlusions. Two patients with borderline velopharyngeal function preoperatively developed velopharyngeal insufficiency postoperatively that did not resolve 6 months postoperatively, necessitating further surgery. Families reported ease of turning with minimal discomfort reported by patients. All patients maintained normal mouth opening during and after the distraction phase. Two of the patients developed localized pin site infections after the distraction phase that were treated successfully with oral antibiotics.
Conclusion: The trans-nasal Le Fort I distractor can be an effective device to advance the deficient maxilla and is well tolerated by patients.