Resorbable plate osteosynthesis of dislocated or pathological mandibular fractures: a prospective clinical trial of two amorphous L-/DL-lactide copolymer 2-mm miniplate systems.

The purpose of this study was to evaluate the indication for resorbable miniplates in traumatic and pathological mandibular fractures. Two resorbable miniplate systems, the 2.0-mm MacroSorb (Macropore, San Diego, Calif.) and the PolyMax (Synthes, Oberdorf, Switzerland), were prospectively used in 24 mandibular osteosyntheses. Made from amorphous 70:30 poly-L/DL-lactide, amorphous copolymer plates have not yet been evaluated for mandibular osteosyntheses. The main advantage of the amorphous copolymer-structure is continuous hydrolysis through water penetration into the implant body during the first 6 months. Hydrolysis breaks the copolymer chains into smaller particles that later become degraded through phagocytotic cells. Twelve patients, aged 13 to 83 years, were treated after providing informed consent. Fourteen dentate patients with moderately dislocated traumatic fractures and two edentulous atrophic and dislocated traumatic mandibular fractures were treated. Two patients with pathological fractures due to osteomyelitis received osteosynthesis after sequestrectomy. Histological specimens of the plates, screws, and surrounding soft tissues were taken after 3, 6, 9, and 12 months in secondary dental implant operations. A total of 22 osteosyntheses healed well without clinical or radiological signs of dislocation, insufficient or excess formation of callus, pseudarthrosis, or plate fracture. The follow-up time ranged from 4 to 22 months. One patient with osteomyelitis worsened because of widespread osseous infection, and one with atrophic fracture developed a bland fibrous pseudarthrosis. The histological specimens showed a moderate inflammatory foreign body reaction. No sinuous drainage or clinically apparent inflammation occurred. The presented osteosynthesis systems showed reliable stability for mandibular osteosynthesis in cooperative patients; however, two treatment failures occurred (8 percent). Disadvantages of the resorbable osteosyntheses were costs, greater diameter, screw breakage, and the need to place the screws vertically to the plate. The use of resorbable osteosyntheses in dislocated fractures should be further evaluated in controlled studies.