Evaluation of Customized Polyether Ether Ketone Implant in Reconstruction of Orbital Floor Fractures (Clinical Trial)”

Abstract

INTRODUCTION:Orbital floor fracture is one of the most common maxillofacial fracture. Hence, many clinical methods were implemented for improvement of the techniques used in treating orbital floor fractures. Poly ether ether ketone had been widely used in reconstruction field due to its superb compatibility and proper mechanical properties. AIM OF THIS STUDY:To evaluate the clinical efficacy and radiographic performance of customized PEEK implant in the treatment of patients with orbital floor fracture. MATERIALS AND METHODS: 9 patients with recent orbital floor fracture were selected. All patients were treated using customized PEEK implants in orbital floor reconstruction. Patients were evaluated after 24-hours, one, four and six weeks for enophthalmos, diplopia, ocular motility and infraorbital nerve function in comparison with preoperative status. In addition, a radiographic investigation was performed immediately to confirm the proper placement of the implant and complete release of orbital soft tissue from the maxillary sinus. RESULT: the study was conducted on seven patients with ZMC fracture and 2 patients with blow-out fracture. None of the enrolled patients showed postoperative diplopia. Six out of the enrolled nine patients in this study reported a subjective abnormal sensation in the course of the affected infraorbital nerve at the first follow-up period. However, all patients regained normal sensation by the end of the follow-up period. The difference of the rate of postoperative ocular complications was statistically significant over the follow-up periods (p=0.036). CONCLUSION:The favorable clinical performance of the patient-specific PEEK sheet in the management of orbital floor defects makes it an exemplary reconstructive alternative with superb compatibility, great surgical precision and predictability.