Abstract:Objective To evaluate the clinical results and advantages of 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 the Department of Otorhinolaryngology Head and Neck Surgery of the Ninth People Hospital Affiliated to Shanghai Jiao Tong University School of Medicine 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 requires assembling during the surgery, with or without simultaneous hearing reconstruction. Operation duration, operation success rate, scores of symmetry of the auricle and fine structure of the auricle, patient satisfaction together with surgical complications were recorded respectively. Results All reconstructive operations were successful, with no report of adverse event or complications. The mean speech recognition threshold was improved by 43.46 dB HL and all maximum speech recognition scores reached 100%. The experimental group shows 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 (9.7 points) was higher than the control group (8.9 points) . Conclusion One-stage ear reconstruction for microtia using 3D patient-specific custom-made artificial material ear scaffolds proves to be safe and effective, which also available for simultaneous hearing reconstruction. in one-stage ear reconstruction for microtia which can be used as one of the methods of auricular reconstruction. Clinical utility suggests 3D patient-specific custom-made artificial material ear scaffolds to be an excellent choice for auricular reconstruction.