Patient-Specific Le Fort I Osteotomy Plates Are More Stable than Stock Plates in Patients with Cleft Lip and Palate.

Background: There is evidence that patient-specific plate fixation for Le Fort I osteotomies (LFI) is more stable than traditional plate fixation. The purpose of this study was to evaluate stability of LFI in patients with cleft lip and palate and determine stability differences between patient-specific and stock plates.

Methods: Consecutive patients with cleft lip and palate who underwent isolated LFI by one surgeon (B.L.P.) between 2016 and 2021 were included. The predictor variable was type of plate used for fixation (patient-specific or stock). The outcome variable was magnitude of relapse in the vertical (nasion to A point) and horizontal planes (basion to A point) at 1 year after LFI using 3-dimensional cone beam computed tomography. Statistical analysis included independent samples t , Mann-Whitney U , Fisher exact, and chi-square tests. Values of P < 0.05 were significant.

Results: The sample included 63 subjects; 23 in the patient-specific group (36.5%) and 40 in the stock group (63.5%). Groups were comparable by sex, race, age at surgery, cleft type, presence of pharyngeal flap, and magnitude of horizontal movement ( P > 0.136 for all). Subjects who underwent patient-specific plate fixation were less likely to have greater than or equal to 1-mm change at 1 year in the horizontal (4.3% versus 50.0%; P < 0.001) and vertical planes (4.3% versus 65.0%; P < 0.001) compared with stock plates. For patients who had greater than 10-mm horizontal advancement, the patient-specific plates had significantly less relapse (patient-specific plates, 0.105 ± 0.317 mm; stock plates, 1.888 ± 1.125 mm; P = 0.003).

Conclusion: Patient-specific plate fixation of LFI is more stable and demonstrates less relapse after 1 year than stock plates.

Clinical question/level of evidence: Therapeutic, III.