Analysis of the use of classical compression–distraction devices and the latest device for continuous distraction

Abstract

BACKGROUND: The device used in bone tissue fragment mechanical displacement by expanding the piston between rigidly fixed device legs on the bone fragments is known in classical compression–distraction osteogenesis. In such cases, the control of the displacement is partly left to the patient, since the screw turning must be performed in four sessions per day, and the doctor does not constantly have the opportunity to do it personally, which can lead to uncontrollable results of bone regeneration. To fully control the patient's treatment during distraction, a device that operates continuously and autonomously is required. AIM: Creation and experimental testing of an automatic distraction device for continuous distraction followed by a study of the obtained bone regenerates and its implementation in practical maxillofacial surgery. MATERIALS AND METHODS: To fully control the patient’s treatment during the distraction, we developed an unparalleled distraction device based on the principle of continuous bone fragment separation, with a motor in which the piston is activated by an electrochemical reaction. The device performs distraction continuously, around the clock, and autonomously under the control and monitoring of the software and the possibility of remote access. This study included analysis of statistical data on patient treatment in the Russian University of Medicine Department of Pediatric Maxillofacial Surgery Clinic between 2010 and 2021, development and bench testing of devices and electronics, clinical trials of models of devices for continuous distraction at various rates (1, 2, and 3 mm/day) on experimental animals (dogs), X-ray control at the stages of testing, research and analysis of the morphological structure of the resulting bone regenerates, creation of clinical guidelines for the use of a continuous distraction day device, and identification of its advantages compared with the classic fractional compression–distraction device. RESULTS: Statistical data analysis revealed that 362 patients were treated with distraction devices. This is a relatively high percentage in relation to all patients in the clinic. Studies of the morphological structure of regenerates obtained by continuous distraction with our latest device revealed a higher rate and control of regenerates, good quality characteristics, and histomorphological maturity, most pronounced in regenerates obtained by continuous distraction at a rate of 2 mm/day. CONCLUSION: The need for treatment with distraction osteogenesis in the department’s clinic is rather high; hence, this process should be controlled to improve treatment quality and speed. Our automatic distraction device designed for continuous distraction may be implemented and applied in practical medicine at an appropriate rate of 2 mm/day.