Alar Batten Graft vs Latera for Nasal Valve Collapse

Not Applicable

Withdrawn

• Conditions: Nasal Valve Incompetence

• Registration Number: NCT03793218
• Lead Sponsor: University of Virginia

Brief Summary

Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction, with more easily addressed pathologies such as posterior septal deviation and inferior turbinate hypertrophy often being over-diagnosed. Nasal valve obstruction, particularly dynamic nasal sidewall collapse, is of significant interest to the rhinoplasty surgeon. Traditionally, collapse of the nasal sidewall has been addressed via structural cartilage grafting, with alar batten grafting being the most commonly used method to provide support to the weak nasal sidewall. Recently, an absorbable nasal implant, comprised of a polylactic acid copolymer, has been advocated for supporting the nasal sidewall and relieving nasal obstruction. There are several proposed advantages of the implant over traditional operative techniques, namely the ease of endonasal insertion, which can be performed in the outpatient clinic setting. Preliminary investigations demonstrate subjective improvement in nasal obstruction with use of the implant, however, there has been no direct comparison with traditional techniques utilizing cartilage grafting.

This study is being done at both UVa and in Oregon. This prospective study will randomize patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of two groups undergoing treatment with either endonasal batten grafting or the absorbable Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy of both techniques. Subjects will be blinded to the surgical intervention they receive.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-28
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-04
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Documented physical exam findings of septal deviation
• Bilateral nasal sidewall collapse on inspiration
• Subjective improvement in nasal obstruction with use of the modified Cottle maneuver

Exclusion Criteria

• Prior septorhinoplasty
• Obvious trauma to the nose causing nasal obstruction
• Inflammatory conditions such as chronic rhinosinusitis with nasal polyposis
• Patients using chronic topical nasal decongestants or illicit intranasal drug use
• Prisoners, cognitively impaired, non-English speaking subjects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
12 Month NOSE Score	12 months	Mean change in Nose score at 12 month post-op visit

Secondary Outcome Measures

Name	Time	Method
24 Month NOSE Score	24 months	Mean change in Nose score at 24 month post-op visit
1 Month NOSE Score	1 month	Mean change in Nose score at 1 month post-op visit
6 Month NOSE Score	6 months	Mean change in Nose score at 6 month post-op visit