Abstract
Two second-generation PLLA/PGA bioresorbable osteosynthetic plate systems for oral and maxillofacial surgery are available in Japan. The two systems have different PLLA-PGA component ratios (RapidSorb®, 85:15; Lactosorb®, 82:18) and plate and screw shapes. We conducted a retrospective study to compare our clinical evaluation and examine the incidence of postoperative complications between the two plate systems. A retrospective survey was conducted in 148 patients (midfacial fracture/trauma (68.2%) and dentofacial deformity patients (31.8%); males (54.7%); median age, 37.5 years) treated using maxillofacial osteosynthetic plate systems. The complications included plate exposure (7.4%), infection, (2.7%), and plate breakage (0.7%). Multivariate logistic regression analysis showed a significant correlation between sex (female), plate system (Lactosorb®), number of plates, and pyriform aperture and periorbital sites of plate placement (p < 0.05). Additionally, the propensity score-adjusted model showed a significant correlation between Lactosorb® and postoperative complications (odds ratio 1.007 (95% confidence interval, 1.001–1.055), p < 0.01). However, the two plate systems showed a low incidence rate of complications, and the plate integration and survivability were similar using 2.0-mm or 1.5-mm resorbable plate regardless of the plate system. Our findings suggest that female sex and a greater number of plates are risk factors for postoperative complications, whereas pyriform aperture and periorbital plate placements reduce the risk.
Highlights
IntroductionBioresorbable and biodegradable osteosynthetic fixation plate systems have been considered an effective fixation system that offers several advantages over titanium fixation, including the absence of corrosion and metal accumulation in tissues and the need to remove the implants after osseous healing [1]
Bioresorbable and biodegradable osteosynthetic fixation plate systems have been considered an effective fixation system that offers several advantages over titanium fixation, including the absence of corrosion and metal accumulation in tissues and the need to remove the implants after osseous healing [1].For maxillofacial osteosynthesis, we used poly-L-lactic acid (PLLA) and poly-D-lactic acid (PDLA), the first-generation bioresorbable osteosynthetic poly materials [2]
The patients who underwent maxillofacial surgeries of the midfacial region, namely, midfacial fracture/trauma or maxillary osteotomy for dentofacial deformity surgery using the bioresorbable materials of PLLA/polyglycolic acid (PGA) copolymer plate systems
Summary
Bioresorbable and biodegradable osteosynthetic fixation plate systems have been considered an effective fixation system that offers several advantages over titanium fixation, including the absence of corrosion and metal accumulation in tissues and the need to remove the implants after osseous healing [1]. We used poly-L-lactic acid (PLLA) and poly-D-lactic acid (PDLA), the first-generation bioresorbable osteosynthetic poly materials [2]. This bioresorbable osteofixation implant material is free of toxic and mutagenic effects. Some critical problems are related to using this first regenerative bioresorbable materials, such as an inflammatory response, higher refracture rates, insufficient mechanical properties/support, foreign-body reactions, a late-degradation tissue response, and infection due to its crystallinity and hydrophobicity. Bioresorption with complete loss of strength in vitro does not occur within the first two years of implantation [3]
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