Journal
EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY
Volume 279, Issue 4, Pages 1943-1950Publisher
SPRINGER
DOI: 10.1007/s00405-021-06996-y
Keywords
Printing; Three-Dimensional; Prostheses and Implants; Nasal Septum; Polycaprolactone; Tissue Scaffolds
Categories
Funding
- National Research Foundation of Korea (NRF) - Ministry of Education [2020R1I1A1A01051844]
- Bio & Medical Technology Development Program of the National Research Foundation (NRF) - Ministry of Science ICT [2019M3A9H2032424, 2019M3E5D5064110]
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The study found that the use of 3D-printed bioresorbable PCL nasal implants for nasal septal deformity reconstruction demonstrated long-term clinical efficacy and safety.
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 d:0.09; p = 0.711) or nasal volume (Cohen's d:0.26; p = 0.356), the area of the ostiomeatal unit (Cohen's d:0.49; p = 0.064), septum angles (Cohen's d:0.18; p = 0.831), the NOSE scale (Cohen's d:0.14; p = 0.621), or patients' subjective satisfaction (Cohen's d:0.52; 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.
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