Long-term efficacy and safety of 3D printed implant in patients with nasal septal deformities.

ABSTRACT

PURPOSE: To investigate the long-term safety and efficacy of a 3D-printed bioresorbable polycaprolactone (PCL) nasal implant for nasal septal deformity reconstruction. METHODS: Fourteen patients who had undergone nasal septum reconstruction surgery using 3D-printed PCL nasal septal implants were enrolled. The primary outcome was the change in total Nasal Obstruction Symptom Evaluation (NOSE) scale scores between postoperative 3 months and current status (3.59 ± 0.51 years). The secondary outcomes were changes in the minimum cross-sectional area (MCA) and volume of both nasal cavities based on acoustic rhinometry, the cross-sectional area of the ostiomeatal unit, and the nasal septum angle of the paranasal sinus (PNS) in computed tomography (CT) images, and a visual analog scale (VAS) of the patients' subjective satisfaction. RESULTS: The results showed no significant changes in the MCAs (Cohen's d0.09; p = 0.711) or nasal volume (Cohen's d0.26; p = 0.356), the area of the ostiomeatal unit (Cohen's d0.49; p = 0.064), septum angles (Cohen's d0.18; p = 0.831), the NOSE scale (Cohen's d0.14; p = 0.621), or patients' subjective satisfaction (Cohen's d0.52; p = 0.076) during the follow-up period. CONCLUSIONS: This homogeneous composite microporous PCL nasal septal implant demonstrated long-term clinical efficacy and safety in human tissues that required maintenance of mechanical strength. Therefore, the indications for this implant could extend to various other craniofacial reconstructions in the future.