Development of Multi-functional rigid external distraction£¨M-RED£© for craniomaxillofacial anomalies: experimental studies

Objective: To introduce Multi-functional rigid external distraction(M-RED) developed by the authors and results of experimental study. Methods: Based on the demand of clinical use and experimental studies, M-RED was developed. Required biomechanics were evaluated and animal studies were undertaken in 8 Rhesus monkeys with 8 M-REDs. Results: The M-RED were State-approved products made of Titanium alloy and permitted for use in human. The pull and twist force tests demonstrated that the loading capability of them were larger than 10 kgf and 6 kgf respectively. The horizontal space in between the two fixing parts was < 0.1 mm. Animal studies demonstrated that there was no rejection response of the tissues. All results were satisfactory with good distraction osteogenesis. Conclusions: Distraction Osteogenesis has become an essential treatment modality for patients with craniomaxillofacial anomalies. Many craniofacial patients with maxillary and midface skeletal hypoplasia can now be effectively treated utilizing the principles of distraction osteogenesis. The M-RED has unique advantages over traditional orthognathic surgical methods for the treatment of patients with severe maxillary and midface deficiencies.