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Reviews on Recent Clinical Trials

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ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Clinical Trial

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

Author(s): Shahrokh Raisian, Hamid Reza Fallahi, Kazem S. Khiabani, Mehdi Heidarizadeh* and Sadaf Azdoo

Volume 12, Issue 3, 2017

Page: [154 - 158] Pages: 5

DOI: 10.2174/1574887112666170821165206

Price: $65

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: 3D printed model, diplopia, enophthalmos, orbital fractures, surgical mesh, titanium.

Graphical Abstract

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