Patient-Specific Custom Implants and Virtual Surgical Planning Improve Functional and Aesthetic Outcomes in Complex Midfacial Reconstruction: A Comparative Cohort Study

Objectives: Reconstruction of complex midfacial defects remains challenging due to the need to restore three-dimensional anatomy, functional integrity, and facial symmetry. This study aimed to evaluate the clinical effectiveness, safety, and functional and aesthetic outcomes of patient-specific custom implants (PSCIs) in complex midfacial reconstruction. Additionally, we assessed whether virtual surgical planning (VSP) combined with PSCIs reduces operative time and improves postoperative symmetry and patient-reported outcomes. Materials and Methods: A retrospective comparative cohort study was conducted using prospectively recorded clinical data from patients treated with PSCI/VSP between January 2021 and June 2025 and a historical control cohort treated with standard pre-shaped implants. Eighty-seven consecutive patients undergoing reconstruction of acquired or post-oncologic midfacial defects using titanium or PEEK patient-specific implants were enrolled. Preoperative VSP was performed in all cases. The principal endpoint was postoperative facial symmetry assessed by three-dimensional photogrammetry. Secondary functional outcomes included ocular position and nasal airway patency. Secondary outcomes included operative time, complication rates, implant-related morbidity, and patient-reported outcome measures (FACE-Q) at 12 months. Outcomes were compared with a historical cohort reconstructed with standard pre-shaped implants. Results: Eighty-two patients completed at least 12 months of follow-up. PSCI reconstruction demonstrated significantly improved postoperative symmetry (mean deviation 1.8 +/- 0.6 mm vs. 3.4 +/- 1.1 mm in controls, p < 0.001) and higher patient satisfaction scores at 12 months (FACE-Q overall satisfaction score 82.8 +/- 9.3 vs. 69.7 +/- 11.2, p < 0.001). Mean operative time was reduced by approximately 24.7%, and intraoperative implant modification was required in only 6% of cases compared with 48% in the control group. The overall complication rate was 11%, with implant removal required in 2.4% of patients. Functional outcomes showed significant improvements in orbital positioning and nasal airway patency. Conclusions: Patient-specific custom implants combined with virtual surgical planning provide reliable and reproducible reconstruction of complex midfacial defects. This approach significantly improves facial symmetry, patient satisfaction, and operative efficiency while maintaining low complication rates. PSCIs should be considered a preferred reconstructive option in selected patients requiring complex maxillofacial reconstruction.