Treatment of malar and midfacial fractures with osteoconductive forged unsintered hydroxyapatite and poly-L-lactide composite internal fixation devices.

To evaluate the internal fixation of malar and midfacial fractures, long-term results, and biocompatibility of osteoconductive internal fixation devices composed of a forged composite of unsintered hydroxyapatite and poly-L-lactide (F-u-HA/PLLA). From January 2006 to June 2010, 29 patients (24 males and 5 females; age 33 ± 15 years) were included in the present prospective study. The fracture type was malar in 24 patients, midfacial in 5, isolated orbital floor blowout in 2, and frontal sinus, cranial base in 2 patients. The fractures were fixed with internal fixation devices; these were plates and screws composed of F-u-HA/PLLA. The 24 patients with malar fractures were treated with a single 4-hole L-plate or a straight plate at the infrazygomatic crest. All fractures with internal fixation using devices composed of F-u-HA/PLLA healed well. All malar and midfacial fractures had satisfactory long-term stability. The follow-up examinations at 12 to 67 months after surgery showed that most patients had no complaints, although 2 patients (15%) had a foreign body reaction that was treated by implant removal, with complete symptom resolution. At 5 years after fracture fixation, 2 patients had ultrasound and 2 had radiographic evidence of residual material. An exemplar biopsy showed direct bone growth into the material. In patients with malar and midfacial fractures, hardware composed of the F-u-HA/PLLA composite provided reliable and satisfactory internal fixation, intraoperative handling, long-term stability, and biocompatibility. Direct bone growth into the material could be histopathologically exemplified, in contrast to previous polymer fixations that were resorbed and surrounded by a connective tissue layer. This finding indicates that long-term F-u-HA/PLLA residual material will be included into the remodeled bone, which was confirmed on long-term follow-up radiographs.