Customized Titanium Mesh Based on the 3D Printed Model vs. Manual Intraoperative Bending of Titanium Mesh for Reconstructing of Orbital Bone Fracture: A Randomized Clinical Trial.

Abstract

This study was aimed to compare the efficacy of customized patient-specific titanium mesh based on 3D printed model with intra-operative bending of titanium mesh for reconstructing of orbital floor fracture. This study was prospectively conducted on 10 patients with unilateral orbital floor fractures caused by accident or falls. In intervention group (n=5), the CT-scan slices were used for generating 3D reconstruction of both affected and unaffected orbits. Then, a 3D printed template of mirrored unaffected orbit was produced to mold the titanium mesh. The titanium mesh in conventional group (n=5) was bended only manually and intraoperatively by surgeon and positioned over the bony defect. All patients were followed-up within 1 week, 1 month and 4 months after surgery for assessing enophthalmos, diplopia and other complications. Of 10 patients of the study only two patients in intervention group had preoperative vertical dystopia or diplopia which had been resolved after intervention. The mean enophthalmos at baseline and 1 week, 1 month and 4 months after surgery in control group were 3.8±0.7, 2.4±0.8, 2.4±0.8, and 2.4±0.8 mm, respectively, and in intervention group were 2.6±0.8, 0.35 ± 0.4, 0.35 ± 0.4 and 0.35 ± 0.4 mm, respectively. The mean enophthalmos did not differ significantly at baseline between two groups, while two groups showed significant difference after surgery. Finally, we concluded that the placement of patient-specific titanium implant for reconstructing of orbital bone fracture led to better outcomes when compared to manual bending in terms of enophthalmos and other complications.