Objectives: The aim of this study was to compare the effectiveness and complications of biodegradable osteosynthesis versus titanium osteosynthesis in maxillofacial surgery.
Material and method: After power analysis 230 consecutive patients in 4 different centers were randomized to titanium (KLS Martin) or biodegradable osteosynthesis (Inion). Included were healthy patients with fractures of maxilla, mandible and zygomatic complex as well as Le Fort 1 osteotomies and bilateral sagittal split osteotomies. Primary outcome was bone healing, and secondary outcomes were handling-properties and complications. Patients were evaluated until 52 weeks postoperative.
Results: 7 protocol-violating-patients were excluded from analysis. In 25 biodegradable-randomized patients it was preoperatively decided to switch to titanium for different reasons. After 8 weeks there was inadequate bone healing in 1 patient in the titanium group and in 5 patients in the biodegradable group (intention-to-treat: p = 0.11). The handling properties of titanium on a 1-10 scale were about 1.5 point higher as compared to Inion (significant differences). Until 52 weeks postoperative plates were removed in 11 of the 123 patients treated with titanium and in 18 of the 71 patients treated with Inion because of inflammation ( p = 0.002). 29 patients were lost-to-follow-up.
Summary: There is no significant difference between Inion and titanium in effectiveness (bone healing) for treatment of maxillofacial fractures and osteotomies. The handling properties of Inion are inferior and complications until 52 weeks postoperative are higher.
Conflict of interest: None declared.