Zachary T Root, Thomas J Lepley, Kanghyun Kim, Aspen R Schneller, Songzhu Zhao, Raymond Wen, Veronica L Formanek, Sarah M Sussman, Joseph S Lee, Ahmad Odeh, Lai Wei, Kathleen M Kelly, Bradley A Otto, Kai Zhao
{"title":"Optimizing Corticosteroid Sinonasal Irrigation Outcomes Through 3D Printing: A Randomized Pilot Clinical Trial.","authors":"Zachary T Root, Thomas J Lepley, Kanghyun Kim, Aspen R Schneller, Songzhu Zhao, Raymond Wen, Veronica L Formanek, Sarah M Sussman, Joseph S Lee, Ahmad Odeh, Lai Wei, Kathleen M Kelly, Bradley A Otto, Kai Zhao","doi":"10.1002/oto2.70036","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Topical corticosteroid irrigation plays critical role in the management of chronic rhinosinusitis (CRS). Yet, its efficacy can be highly variable. We sought to determine if personalized, 3-dimensional (3D)-printed nasal models can optimize head positioning and irrigation parameters, therefore improving patient outcomes.</p><p><strong>Study design: </strong>Randomized, single-blinded clinical trial.</p><p><strong>Setting: </strong>Tertiary medical center from November 2021 to July 2023.</p><p><strong>Methods: </strong>Sixty-two patients with CRS were randomized into either control (CG), backfill (BG), or model (MG) groups; daily 2 mg mometasone irrigations were then performed for 2 months with either standard head-forward and natural side-tilt position (CG), a head tilt of 90° to the side with fluid entering the lower nostril (BG), or in an optimized position as determined by a patient-specific 3D printed irrigation model (MG), respectively.</p><p><strong>Results: </strong>A total of 36 patients completed the trial (CG: N = 14/23; BG N = 11/23, MG: N = 11/16). Significant posttreatment improvement in Lund-Mackay (LM) scoring was only observed in the MG (-3.73, 95% confidence interval = -5.71, -1.75; <i>P</i> < .001). Patient-reported outcome measures (Nasal Obstruction Symptom Evaluation, Sinonasal Outcome Test-22, and Visual Analog Scale of nasal congestion) improved significantly among all groups. Optimal model penetration scores significantly correlated to posttreatment MG LM score (Spearman's <i>r</i> = 0.65, <i>P</i> < .05). Among all groups, patients with prior endoscopic sinus surgery (ESS) (n = 19) had objectively less opacification at baseline; however, experienced the same degree of opacification reduction and symptom reduction as those without prior ESS (n = 17).</p><p><strong>Conclusion: </strong>The use of 3D printing to personalize head positioning may significantly improve objective corticosteroid irrigation outcomes. Mometasone irrigation may have similar subjective and objective effects on patients regardless of prior surgical history.</p><p><strong>Level of evidence: </strong>Level 1 prospective, randomized, single-blinded clinical trial NCT06118554.</p>","PeriodicalId":19697,"journal":{"name":"OTO Open","volume":"8 4","pages":"e70036"},"PeriodicalIF":1.8000,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11480515/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"OTO Open","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/oto2.70036","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"OTORHINOLARYNGOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Objective: Topical corticosteroid irrigation plays critical role in the management of chronic rhinosinusitis (CRS). Yet, its efficacy can be highly variable. We sought to determine if personalized, 3-dimensional (3D)-printed nasal models can optimize head positioning and irrigation parameters, therefore improving patient outcomes.
Study design: Randomized, single-blinded clinical trial.
Setting: Tertiary medical center from November 2021 to July 2023.
Methods: Sixty-two patients with CRS were randomized into either control (CG), backfill (BG), or model (MG) groups; daily 2 mg mometasone irrigations were then performed for 2 months with either standard head-forward and natural side-tilt position (CG), a head tilt of 90° to the side with fluid entering the lower nostril (BG), or in an optimized position as determined by a patient-specific 3D printed irrigation model (MG), respectively.
Results: A total of 36 patients completed the trial (CG: N = 14/23; BG N = 11/23, MG: N = 11/16). Significant posttreatment improvement in Lund-Mackay (LM) scoring was only observed in the MG (-3.73, 95% confidence interval = -5.71, -1.75; P < .001). Patient-reported outcome measures (Nasal Obstruction Symptom Evaluation, Sinonasal Outcome Test-22, and Visual Analog Scale of nasal congestion) improved significantly among all groups. Optimal model penetration scores significantly correlated to posttreatment MG LM score (Spearman's r = 0.65, P < .05). Among all groups, patients with prior endoscopic sinus surgery (ESS) (n = 19) had objectively less opacification at baseline; however, experienced the same degree of opacification reduction and symptom reduction as those without prior ESS (n = 17).
Conclusion: The use of 3D printing to personalize head positioning may significantly improve objective corticosteroid irrigation outcomes. Mometasone irrigation may have similar subjective and objective effects on patients regardless of prior surgical history.
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