Virtual surgical planning and 3D custom-made implants in the management of orbital floor fractures: A case control study

Background: Orbital floor fractures are among the most frequent facial injuries, and precise reconstruction is essential to prevent both functional and aesthetic complications. Virtual Surgical Planning (VSP) combined with pre-shaped titanium mesh has transformed orbital reconstruction. This study aimed to evaluate whether VSP-assisted surgery with pre-modeled mesh provides greater accuracy and reduced operative times compared with conventional intraoperative mesh shaping. Methods: A case-control study was performed on 52 patients treated at the "Federico II" University Hospital of Naples for large pure orbital floor fractures. Twenty-four patients (Group A) underwent VSP-assisted reconstruction using a preformed titanium mesh, while twenty-eight patients (Group B) received conventional intraoperative mesh modeling. Operative time, postoperative diplopia, infraorbital sensory disturbance, mesh malposition, screw loosening, and infection were compared in the two groups. Clinical and radiological follow-up was conducted at 12 months. Results: Median operative time was significantly shorter in Group A compared with Group B (55 min [IQR 50-65] vs. 110 min [IQR 98-125]; p < 0.001). Persistent diplopia occurred in 4 % of patients in Group A and 28.6 % in Group B (p = 0.028). Implant malposition was observed exclusively in Group B (25 % vs. 0 %; p = 0.011). Other postoperative complications, including infraorbital nerve alterations, eyelid malposition, wound dehiscence, screw loss, and infection, were more frequent in Group B but did not reach statistical significance. No cases of postoperative ocular motility limitation or iatrogenic fracture were observed in either group. Conclusions: VSP with pre-modeled titanium mesh significantly reduces operative time and postoperative complications, enhancing reconstructive precision and outcomes in orbital floor fracture management. This virtual protocol is useful for reducing the costs and waiting times of custom-made implants, manufactured by external companies.