Is There a Difference Between Conventional and Custom-Made Red-II in Le Fort III?

Craniosynostosis syndromes with midfacial hypoplasia can be treated with Le Fort III distraction osteogenesis (DO) using an external distraction system. The authors compared outcomes between the conventional and custom-made rigid external distraction (RED II) systems. Evaluations of 18 patients with craniosynostosis syndrome who underwent Le Fort III DO using the external RED II systems between 2006 and 2025 were performed. Demographic data, surgery-specific variables, and complications were collected and analyzed retrospectively using medical records. A comparative analysis was performed between the 2 systems. In the conventional RED II group (n=13), the median age at surgery was 8.6 years and the median distraction length was 20 mm. Major complications were observed in 38% of patients. Minor complications occurred in 23% and device-related complications in 15%. In the custom-made RED II group (n=5), the median age at surgery was 6.1 years and the median elongation length was 23 mm. Major complications occurred in 40% of patients. Minor complications were observed in 40%, and device-related complications in 60%. The custom-made RED II system was associated with a higher rate of device-related complications compared with the conventional system. Both major and minor complications occurred more frequently with the custom-made device. The differences were clinically relevant but did not reach statistical significance. The custom-made RED II system demonstrated a shorter operative time and a longer distraction. These findings may help guide surgeons' selection of an external distraction system in clinical practice.