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.