The use of anatomically drop-shaped bioactive glass S53P4 implants in the reconstruction of orbital floor fractures—A prospective long-term follow-up study

An isolated fracture of the orbital floor needs reconstruction if there is a clear herniation of adipose tissue or of the rectus inferior muscle into the maxillary sinus. A prospective study was carried out treating 20 patients with an isolated blow-out fracture of the orbital floor or with a combined zygomatico-orbito-maxillary complex fracture, using a newly designed anatomically drop-shaped implants made of bioactive glass (BAG) S53P4. Computed tomography (CT) was performed immediately postoperatively to confirm the correct position of the plate. The patients were followed up for an average of 32 months clinically and radiologically with magnetic resonance imaging (MRI) for an average of 31 months. None of the patients had any signs of complications related to the implant and the clinical outcome was very good. None of the patients had persisting diplopia. The level of the pupillas was normal in 15 of 20 patients. Minor hypo-ophthalmos ranging from 0.5 to 1.0 mm was observed in three patients, and moderate hypo-ophthalmos of 2.0 mm was seen in one patient. Hyperophthalmos of 1.0 mm was seen in one patient. Minor enophthalmos on the operated side ranging from 0.5 to 1.0 mm was seen in eight patients. Mild to moderate paraesthesia of the infraorbital nerve was observed in six patients. The immediate postoperative CT and the long term follow-up MRI revealed that the drop-shaped BAG implants retained their correct position in the orbital floor and did not show any evidence of losing their original shape or material resorption. No adverse tissue reaction was associated with the material. Due to the anatomical drop shape, the implants could successfully maintain the orbital volume and compensate for the retrobulbar adipose tissue atrophy.