The Safety and Efficacy of a Bioabsorbable Implant for Correction of Cartilaginous Septal Deviation.

Steven E Davis, Greg E Davis
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Abstract

Introduction: Nasal septal deviation (NSD) is a leading cause of nasal airway obstruction, a condition that adversely affects quality of life. Septoplasty, typically performed with inferior turbinate reduction (ITR), is a common treatment to correct NSD.

Methods: We conducted a prospective feasibility study of a novel, minimally-invasive implant (SeptAlignTM) to correct cartilaginous NSD as an alternative to traditional open septoplasty. The implant was inserted either in the operating room or at the medical office. ITR was performed in conjunction with the implant procedure.

Results: We present 12 month results for 14 participants with mobile cartilaginous NSD. The procedure and implant were well-tolerated. At the 12th month post-procedure, the median Nasal Obstruction Symptom Evaluation (NOSE) score improved 71.8% from baseline (58-15; P = .001) and the median Sino-Nasal Outcome Test-22 (SNOT-22) score improved 60.3% from baseline score (37-8; P = .004). Most of the improvement in symptoms occurred within the first month following the procedure at which point 92.9% and 78.6% of participants were considered NOSE and SNOT-22 responders, respectively.

Conclusion: These initial findings support the safety, tolerability, and early efficacy of the SeptAlignTM implant with concomitant ITR and suggest that the implant procedure can be safely performed in a medical office setting. Based on these promising initial data, larger, randomized, controlled studies should be conducted.

Clinicaltrials: gov:NCT05967169; https://clinicaltrials.gov/study/NCT05967169?term=Spirair&rank=2.

生物可吸收种植体矫正软骨中隔偏曲的安全性和有效性。
鼻中隔偏曲(NSD)是鼻气道阻塞的主要原因,对生活质量有不利影响。中隔成形术通常与下鼻甲复位(ITR)一起进行,是纠正NSD的常用治疗方法。方法:我们对一种新型微创植入物(SeptAlignTM)进行了前瞻性可行性研究,作为传统开放式鼻中隔成形术的替代方案,用于矫正软骨性NSD。植入物是在手术室或医疗办公室植入的。ITR与种植体手术同时进行。结果:我们报告了14例活动软骨NSD患者12个月的结果。手术和植入物的耐受性良好。术后12个月,鼻塞症状评估(NOSE)中位评分较基线提高71.8% (58-15;P = .001),中位鼻预后测试-22 (SNOT-22)评分较基线评分提高60.3% (37-8;P = .004)。大多数症状改善发生在手术后的第一个月内,此时92.9%和78.6%的参与者分别被认为是NOSE和SNOT-22应答者。结论:这些初步研究结果支持SeptAlignTM植入物伴ITR的安全性、耐受性和早期疗效,并提示该植入物可以在医疗办公室环境中安全进行。基于这些有希望的初步数据,应该进行更大规模的随机对照研究。临床试验:政府:NCT05967169;https://clinicaltrials.gov/study/NCT05967169?term=Spirair&rank=2。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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