Patient-Specific Titanium Implants Reduce Hardware-Related Complications Compared to Stock Reconstruction Plates for Virtually Guided Fibular Free Flaps in Head and Neck Reconstruction.

[BACKGROUND] Virtual surgical planning (VSP) for composite microvascular free flaps has become the standard-of-care for oncologic head and neck reconstruction. Controversy remains on the routine use of three-dimensional-printed titanium patient-specific implants (PSIs) or traditional hand-contoured stock reconstruction plates.

[PURPOSE] The purpose of this study was to compare hardware-related complications of PSIs versus stock reconstruction plates among subjects undergoing VSP-guided fibular free flap reconstructions.

[STUDY DESIGN/SETTING/SAMPLE] A retrospective cohort study of subjects undergoing VSP-guided fibular free flaps at Mayo Clinic between 2014 and 2023 was undertaken. Exclusion criteria included subjects not undergoing a VSP-guided surgery, bony microvascular reconstruction other than a fibular free flap, less than 1 year of postoperative follow-up, and inadequate documentation of requisite clinical variables in the electronic medical record.

[PREDICTOR VARIABLE] The primary predictor variable was the type of reconstruction plate utilized (PSI vs stock plate).

[MAIN OUTCOME VARIABLE] The main outcome variable was potential hardware-related complications defined as: hardware fracture, hardware loosening, postoperative infection, hardware extrusion, hardware removal, nonunion bone healing, and osteoradionecrosis.

[COVARIATES] Covariates included subject age, sex, and preoperative diagnosis.

[ANALYSIS] Associations of complication-free survival with plate type were analyzed with Kaplan-Meier survival curves. Formal associations were calculated using Cox proportional hazards regression analysis, modeling time to complication as the outcome and plate type as the exposure.

[RESULTS] A total of 265 subjects were identified, 183 (69%) receiving PSIs, and 82 (31%) receiving stock plates. Seventy-two subjects (27%) experienced at least 1 postoperative hardware-related complication. Multivariate Cox proportional hazards regression demonstrated that stock plates were nearly twice as likely to experience at least 1 hardware-related complication compared to PSIs (hazard ratio: 1.80, 95% CI: 1.11 to 2.91, P = .0171).

[CONCLUSION AND RELEVANCE] Use of PSIs in the modern era of VSP-guided fibular free flap reconstruction is associated with a nearly 2-fold reduction in postoperative hardware-related complications over stock reconstruction plates.