Primary reconstruction of extensive orbital fractures using two-piece patient-specific implants: the Helsinki protocol

PURPOSE: We present our experience of titanium-milled two-piece patient-specific implants (PSIs) for primary reconstructions of extensive orbital floor and medial wall fractures (EOFMFs) and evaluate their postoperative functional and aesthetic outcomes in relation to commercially available implants. METHODS: We included all patients with primary reconstructions (< 22 days from injury) of EOFMFs treated in our department between January 2011 and October 2020. Extensive orbital floor and medial wall fracture was defined as involvement of orbital floor, medial wall and maxilloethmoidal junction; a fracture defect 5 mm or more; defect size more than a third of both inferior and medial walls; and Jaquiéry classification III or more. Patient characteristics, details of fracture defects and surgeries, postoperative outcomes and implant positions were retrospectively evaluated and compared between study groups. RESULTS: Nineteen patients were included: 5 with two-piece PSIs and 14 with commercial implants. Implant position was good in 4/5 patients with two-piece PSIs and 2/14 with commercial implants. Revision surgery, globe malposition (GMP) > 2 mm, significant diplopia and poor implant position were more frequent in patients with commercial implants than two-piece PSIs. None of the patients with a good overall implant position had any significant postoperative symptoms. CONCLUSION: Extensive orbital fracture reconstructions are somewhat rare, and surgical treatment is associated with a high rate of complications and postoperative symptoms. Titanium-milled two-piece PSIs are well suited for primary reconstructions of EOFMFs, as they lead to more precise reconstructions and fewer postoperative symptoms than commercially available implants.