Clinical Evaluation of an Unsintered Hydroxyapatite/Poly-L-Lactide Osteoconductive Composite Device for the Internal Fixation of Maxillofacial Fractures.

INTRODUCTION

OSTEOTRANS MX (Takiron Co, Ltd, Osaka, Japan) is a resorbable osteosynthetic material composed of an unsintered hydroxyapatite/poly-L-lactide composite, and its osteoconductive capacity has been documented. The authors here report their clinical experience using OSTEOTRANS MX.

METHODS

The authors treated 35 patients (19 men, 16 women; age, 14-88 years; mean ± standard deviation, 38.4 ± 19.9 years) with maxillofacial fractures. The authors used standard surgery to stabilize fractures in all patients, fitting resorbable plates (thickness, 1.0 or 1.4 mm) and screws (diameter, 2 mm) according to Arbeitsgemeinschaft für Osteosynthesefragen/Association (AO) for the Study of Internal Fixation guidelines.

RESULTS

All patients eventually achieved satisfactory healing with favorable restoration of form and function without foreign body reaction. Complications occurred in 3 patients-plate exposure in 2 and discomfort in 1. However, fracture sites healed in all patients. Scanning electron microscopy revealed that the devices bonded directly to the bone without interposition of nonmineralized tissue.

CONCLUSION

OSTEOTRANS MX is a useful material with few complications. Its osteoconductive bioactivity is advantageous for the early functional improvement of maxillofacial fractures.