Development and Clinical Evaluation of MatrixMANDIBLE Subcondylar Plates System (Synthes).

Abstract

In this article, authors report the different steps of development and clinical validation of MatrixMANDIBLE Subcondylar Plates (Synthes, Soletta, Switzerland), a specialized osteosynthesis system developed by Synthes during the past 4 years. Between 2009 and 2013, a total of 62 patients were treated for subcondylar and condylar neck fractures via a preauricular or retromandibular/transparotid approach. The MatrixMANDIBLE Subcondylar Plates System consists of a Trapezoidal Plate, a three-dimensional (3D) 4-hole 1.0-mm plate for smaller fracture areas, the Lambda Plate, a 7-hole 1.0-mm linear plate which mimics the two miniplates technique, and the Strut Plate, a 3D 1.0-mm plate with great versatility of employment. All devices satisfy the principles of a functionally stable osteosynthesis as stated by Champy et al. None of the plates broke and no macroscopic condylar displacement was noted on radiological follow-up. Clinical and functional parameters assessed at 6 months postoperative (mandibular range of motion, pain, dental occlusion) were almost restored. MatrixMANDIBLE Subcondylar Plates System (Synthes) has proved to provide sufficient mechanical stiffness and anatomically accurate fracture reduction to avoid major postoperative drawbacks of subcondylar and condylar neck fractures.