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

ABSTRACT

BACKGROUND: There is evidence that patient-specific plate fixation for Le Fort I osteotomies (LFI) is more stable than traditional plates. The purpose of this study was to evaluate stability of LFI in patients with cleft lip and palate (CLP) and determine stability differences between patient-specific and stock plates. METHODS: Consecutive patients with CLP who underwent isolated LFI by one surgeon (BLP) 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-A point) and horizontal planes (Basion-A point) at one year post LFI using 3-dimensional cone beam computed tomography. Statistical analysis included Independent Samples T-test, Mann-Whitney U, Fisher's exact and Chi-square tests. P<0.05 was significant. RESULTS: The sample included 63 subjects; 23 (36.5%) in the patient-specific group and 40 (63.5%) in the stock group. Groups were comparable by sex, race, age at operation, cleft type, presence of pharyngeal flap and magnitude of horizontal movement (P>0.136, all). Subjects who underwent patient-specific plate fixation were less likely to have ≥1mm change at one year in the horizontal (4.3% vs. 50.0%, p<.001) and vertical planes (4.3% vs. 65.0%, P<.001) compared to stock plates. For patients who had >10mm horizontal advancement, the patient-specific plates had significantly less relapse (patient-specific 0.105mm ± 0.317mm vs. stock 1.888mm ± 1.125mm vs, P=.003). CONCLUSIONS: Patient-specific plate fixation of LFI is more stable and demonstrates less relapse after one year than stock plates. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, III.