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- Title
Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.
- Authors
Stolovitzky, Pablo; Senior, Brent; Ow, Randall A.; Mehendale, Neelesh; Bikhazi, Nadim; Sidle, Douglas M.
- 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.
- Subjects
BIOABSORBABLE implants; RANDOMIZED controlled trials; CONTROL groups; THERAPEUTICS; VALVES
- Publication
International Forum of Allergy & Rhinology, 2019, Vol 9, Issue 8, p850
- ISSN
2042-6976
- Publication type
Article
- DOI
10.1002/alr.22362