Background: Surgical plates have been extensively used in head and neck reconstruction and conventional plates are mass-produced with universal configurations. To overcome disadvantages of conventional surgical plates, we have been exploring patient-specific surgical plates using the three-dimensional (3D) printing technology. We hypothesized that the application of 3D-printed patient-specific surgical plates in head and neck reconstruction is feasible, safe and precise.
Methods: We are conducting a prospective clinical trial to assess the feasibility, safety and accuracy of applying 3D-printed patient-specific surgical plates in head and neck reconstruction. The primary endpoint was the intraoperative success rate. Secondary endpoints included the incidence and severity of postoperative adverse events within six months postoperatively. The accuracy of surgical outcomes was also explored by comparing the planned and final positions of the maxilla, mandible and grafted bone segments.
Results: From December 2016 to October 2017, ten patients were enrolled and underwent head and neck reconstruction using 3D-printed patient-specific surgical plates. The patient-specific surgical plates adapted to bone surface precisely and no plate-bending was performed. The intraoperative success rate was 100%. The average follow-up period was 6.5 months. No major adverse events were observed. The mean absolute distance deviation of integral mandible or maxilla was 1.40 ± 0.63 mm, which showed a high accuracy of reconstruction.
Conclusions: The 3D printing of patient-specific surgical plates could be effective in head and neck reconstruction. Surgical procedures were simplified. The precise jaw reconstruction was achieved with high accuracy. Long-term results with a larger sample size are warranted to support a final conclusion. The study protocol has been registered in ClinicalTrials.gov with a No. of NCT03057223.
Keywords: Computer-aided design; Head and neck neoplasms; Head and neck reconstruction; Internal fixators; Mandibular reconstruction; Maxillary reconstruction; Patient-specific plates; Prospective clinical trial; Selective laser melting; Three-dimensional printing.
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