PURPOSE: The hypothesis for this prospective evaluation is that resorbable plates are equal to the performance of titanium 2-mm plates, regarding healing of the fracture with bone union and restoration of function. To prove this hypothesis, specific end points will be compared with literature norms for titanium 2-mm miniplate rigid fixation. The primary end point variable for this analysis is the union of the fracture and return to normal function. Secondary end point variables included the incidence of complications such as infection, malunion with malocclusion, soft tissue dehiscence, the need for revision surgery, specific technical challenges, operative time, and the learning curve for the surgeon. PATIENTS AND METHODS: This prospective study consisted of a sequential enrollment of 50 fractures that met the inclusion criteria of having a fracture of the mandibular body, symphysis, angle, or ramus, and required an open reduction and internal fixation for stabilization and repair. The resorbable plates and screws used consisted of an amorphous injection molded copolymer of L-lactide/D-lactide/trimethylene carbonate (Inion CPS system, Tampere, Finland). Data were collated and compared with literature norms for titanium plates and also compared with nonrigid fixation data from a prospective study performed on a similar population in the same institution. RESULTS: Clinical and radiographic evaluation indicated union of all fractures at the eighth follow-up visit. Three sites (6%) noted to have clinical signs of infection were treated immediately upon presentation, with fracture union by 8 weeks. There was no need for revision surgery in this series of patients; 12 screw heads fractured during screw placement and were immediately replaced without significant fracture sequelae. CONCLUSION: Based on this limited series of patients, the hypothesis formulated for this study was validated.
PURPOSE: The hypothesis for this prospective evaluation is that resorbable plates are equal to the performance of titanium 2-mm plates, regarding healing of the fracture with bone union and restoration of function. To prove this hypothesis, specific end points will be compared with literature norms for titanium 2-mm miniplate rigid fixation. The primary end point variable for this analysis is the union of the fracture and return to normal function. Secondary end point variables included the incidence of complications such as infection, malunion with malocclusion, soft tissue dehiscence, the need for revision surgery, specific technical challenges, operative time, and the learning curve for the surgeon. PATIENTS AND METHODS: This prospective study consisted of a sequential enrollment of 50 fractures that met the inclusion criteria of having a fracture of the mandibular body, symphysis, angle, or ramus, and required an open reduction and internal fixation for stabilization and repair. The resorbable plates and screws used consisted of an amorphous injection molded copolymer of L-lactide/D-lactide/trimethylene carbonate (Inion CPS system, Tampere, Finland). Data were collated and compared with literature norms for titanium plates and also compared with nonrigid fixation data from a prospective study performed on a similar population in the same institution. RESULTS: Clinical and radiographic evaluation indicated union of all fractures at the eighth follow-up visit. Three sites (6%) noted to have clinical signs of infection were treated immediately upon presentation, with fracture union by 8 weeks. There was no need for revision surgery in this series of patients; 12 screw heads fractured during screw placement and were immediately replaced without significant fracture sequelae. CONCLUSION: Based on this limited series of patients, the hypothesis formulated for this study was validated.