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

  • Rhinology
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

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 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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Data availability

All data files are available from the figureshare database without limitations. (https://doi.org/10.6084/m9.figshare.13646507.v1).

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Funding

This research was supported by the Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education (2020R1I1A1A01051844), the Bio & Medical Technology Development Program of the National Research Foundation (NRF) funded by the Ministry of Science & ICT(2019M3A9H2032424, 2019M3E5D5064110). The sponsors had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Author notes

  1. DoHyun Kim and IlHwan Lee contributed equally to this paper.

Authors and Affiliations

  1. Department of Otolaryngology-Head and Neck Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Banpo-daero 222, Seocho-gu, Seoul, 137-701, Republic of Korea

    Do Hyun Kim & Sung Won Kim

  2. Department of Otolaryngology–Head and Neck Surgery, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea

    Il Hwan Lee

  3. Department of Mechanical Engineering, Korea Polytechnic University, Siheung-Si, Gyeonggi-Do, Korea

    Won-Soo Yun & Jin-Hyung Shim

  4. Research Institute, T&R Biofab Co. Ltd, Siheung-Si, Gyeonggi-Do, Korea

    Won-Soo Yun, Jin-Hyung Shim & Dami Choi

  5. Department of Otolaryngology-Head and Neck Surgery, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 327 Sosa-ro, Bucheon-si, Gyeonggi-Do, 14647, Korea

    Se Hwan Hwang

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  1. Do Hyun Kim
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Corresponding authors

Correspondence to Se Hwan Hwang or Sung Won Kim.

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Conflict of interest

Won-Soo Yun, Jin-Hyung Shim, Dami Choi are affiliated in T&R Biofab. Co. Ltd., and serve as C.E.O., C.T.O., and Research Engineer, respectively.

Ethical approval

This clinical trial was approved by the Institutional Review Board of Seoul St. Mary’s Hospital (KC19DSSV0897). It was conducted according to the Declaration of Helsinki.

Informed consent

The informed consent was obtained from all participants who heard and understood the description of this clinical study.

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Kim, D.H., Lee, I.H., Yun, WS. et al. Long-term efficacy and safety of 3D printed implant in patients with nasal septal deformities. Eur Arch Otorhinolaryngol 279, 1943–1950 (2022). https://doi.org/10.1007/s00405-021-06996-y

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  • DOI: https://doi.org/10.1007/s00405-021-06996-y

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