Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial

Pablo Stolovitzky, Brent Senior, Randall A Ow, Neelesh Mehendale, Nadim Bikhazi, Douglas M Sidle, Pablo Stolovitzky, Brent Senior, Randall A Ow, Neelesh Mehendale, Nadim Bikhazi, Douglas M Sidle

Abstract

Background: Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in-office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control.

Methods: In this prospective, multicenter, single-blinded RCT, 137 patients from 10 clinics were randomized into 2 arms: treatment arm (70 patients) and sham control arm (67 patients). Outcome measures were followed through 3 months after the procedure. The primary endpoint was the responder rate (percentage of patients with reduction in clinical severity by ≥1 category or ≥20% reduction in Nasal Obstruction Symptom Evaluation [NOSE] score).

Results: Before the procedure, there were no statistically significant differences in patient demographics and nasal obstruction symptom measures between the 2 arms. Three months after the procedure, responder rate was significantly higher for the treatment arm compared to the control (82.5% vs 54.7%, p = 0.001). Patients in the treatment arm also had a significantly greater decrease in NOSE score (-42.4 ± 23.4 vs -22.7 ± 27.9, p < 0.0001) and significantly lower visual analogue scale (VAS) scores (-39.0 ± 29.7 vs -13.3 ± 30.0, p < 0.0001) than the sham control arm. Seventeen patients reported 19 procedure/implant-related adverse events, all of which resolved with no clinical sequelae.

Conclusion: Our study shows the safety and effectiveness of the bioabsorbable implant in reducing patients' nasal obstruction symptoms.

Trial registration: ClinicalTrials.gov NCT03400787.

Keywords: disease severity; evidence-based medicine; nasal airway obstruction in-office procedures; quality of life; sham-control.

© 2019 The Authors International Forum of Allergy & Rhinology published by Wiley Periodicals, Inc. on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society.

Figures

Figure 1
Figure 1
Enrollment, randomization, and follow‐up of patients randomized to treatment arm vs sham control arm.
Figure 2
Figure 2
Primary endpoint: comparison between study arms for 3‐month responder rate. Value of p is based on a 1‐sided binomial test of proportions comparing responder rate between study arms with p < 0.025 indicating statistical significance. Implant treatment is superior to sham control.

References

    1. Barrett DM, Casanueva FJ, Cook TA. Management of the nasal valve. Facial Plast Surg Clin North Am. 2016;24:219‐234.
    1. Sheen JH. Spreader graft: a method of reconstructing the roof of the middle nasal vault following rhinoplasty. Plast Reconstr Surg. 1984;73:230‐239.
    1. Goode RL. Surgery of the incompetent nasal valve. Laryngoscope. 1985;95:546‐555.
    1. Most SP. Anterior septal reconstruction: outcomes after a modified extracorporeal septoplasty technique. Arch Facial Plast Surg. 2006;8:202‐207.
    1. Surowitz J, Lee MK, Most SP. Anterior septal reconstruction for treatment of severe caudal septal deviation: clinical severity and outcomes. Otolaryngol Head Neck Surg. 2015;153:27‐33.
    1. Clark DW, Del Signore AG, Raithatha R, Senior BA. Nasal airway obstruction: prevalence and anatomic contributors. Ear Nose Throat J. 2018;97:173‐176.
    1. San Nicoló M, Stelter K, Sadick H, Bas M, Berghaus A. Absorbable implant to treat nasal valve collapse. Facial Plast Surg. 2017;33:233‐240.
    1. San Nicoló M, Stelter K, Sadick H, Bas M, Berghaus A. A 2‐year follow‐up study of an absorbable implant to treat nasal valve collapse. Facial Plast Surg. 2018;34:545‐550.
    1. Stolovitzky P, Sidle DM, Ow RA, Nachlas NE, Most SP. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: outcomes using a bioabsorbable implant. Laryngoscope. 2018;128:2483‐2489.
    1. Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004;130:157‐163.
    1. Stewart MG, Smith TL, Weaver EM, et al. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004;130:283‐290.
    1. Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. 2013;15:358‐361.
    1. Rhee JS, Weaver EM, Park SS, et al. Clinical consensus statement: diagnosis and management of nasal valve compromise. Otolaryngol Head Neck Surg. 2010;143:48‐59.
    1. Fung E, Hong P, Moore C, Taylor SM. The effectiveness of modified Cottle maneuver in predicting outcomes in functional rhinoplasty. Plast Surg Int. 2014;2014:618313.
    1. Wartolowska K, Judge A, Hopewell S, et al. Use of placebo controls in the evaluation of surgery: systematic review. BMJ. 2014;348:g3253.
    1. Macklin R. The ethical problems with sham surgery in clinical research. N Engl J Med. 1999;341:992‐996.
    1. Powell NB, Zonato AI, Weaver EM, et al. Radiofrequency treatment of turbinate hypertrophy in subjects using continuous positive airway pressure: a randomized, double‐blind, placebo‐controlled clinical pilot trial. Laryngoscope. 2001;111:1783‐1790.
    1. Nease CJ, Krempl GA. Radiofrequency treatment of turbinate hypertrophy: a randomized, blinded, placebo‐controlled clinical trial. Otolaryngol Head Neck Surg. 2004;130:291‐299.
    1. Kaptchuk TJ, Goldman P, Stone DA, Stason WB. Do medical devices have enhanced placebo effects? J Clin Epidemiol. 2000;53:786‐792.
    1. Wise RA, Bartlett SJ, Brown ED, et al. Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers. J Allergy Clin Immunol. 2009;124:436‐444.e8.
    1. Floyd EM, Ho S, Patel P, Rosenfeld RM, Gordin E. Systematic review and meta‐analysis of studies evaluating functional rhinoplasty outcomes with the NOSE Score. Otolaryngol Head Neck Surg. 2017;156:809‐815.
    1. Kandathil CK, Spataro EA, Laimi K, Moubayed SP, Most SP, Saltychev M. Repair of the lateral nasal wall in nasal airway obstruction: a systematic review and meta‐analysis. JAMA Facial Plast Surg. 2018;20:307‐313.
    1. Ramakrishnan JB, Danner CJ, Yee SW. The use of porous polyethylene implants to correct nasal valve collapse. Otolaryngol Head Neck Surg. 2007;136:357‐361.
    1. Winkler AA, Soler ZM, Leong PL, Murphy A, Wang TD, Cook TA. Complications associated with alloplastic implants in rhinoplasty. Arch Facial Plast Surg. 2012;14:437‐441.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner