Abstract:Objective To evaluate the clinical effects and advantages of three dimensional (3D) patient-specific custom-made artificial material ear scaffolds in one-stage ear reconstruction for microtia.Methods From June 2021 to March 2022, patients with unilateral microtia from our department were selected, then randomly divided into two groups. Patients in experimental group (n=12) underwent one-stage ear reconstruction using 3D patient-specific custom-made artificial material auricular scaffolds, while the control group (n=12) used off-the-shelf two-piece artificial material auricular scaffolds which required assembling during the surgery, with or without simultaneous hearing reconstruction. Operation time, operation success rate, scores of symmetry and fine structure of the auricle, patient satisfaction together with surgical complications were recorded and compared.Results All reconstructive operations were successful without adverse events and complications. The mean speech recognition threshold was improved by 38.6 dBHL and all maximum speech recognition scores reached 100% in the patients with simultaneous hearing reconstruction. The experimental group showed better outcomes than the control group regarding to symmetry and fineness (P<0.05). The experimental group required fewer operation hours than the control group (P<0.01). The final mean score on each item from patient satisfaction questionnaire of the experimental group was higher than that of the control group.Conclusions One-stage ear reconstruction for microtia using 3D patient-specific custom-made artificial material ear scaffolds is safe and effective, which is also available for simultaneous hearing reconstruction. Clinical utility suggests 3D patient-specific custom-made artificial material ear scaffolds to be an excellent choice for auricular reconstruction.