Alar Batten Graft vs Latera for Nasal Valve Collapse

Nasal Valve Incompetence Clinical Trial

Official title:

A Comparison of Alar Batten Graft to the Latera Nasal Implant for the Treatment of Nasal Valve Collapse

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03793218
• Other study ID #: 20859
• Status: Withdrawn
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2024
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasal Valve Incompetence
• Shock

Intervention

Device:
• Latera Device
This study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant

Procedure:
• Alar Batten Graft
This study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Portland VA Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 Month NOSE Score	Mean change in Nose score at 12 month post-op visit	12 months
Secondary	1 Month NOSE Score	Mean change in Nose score at 1 month post-op visit	1 month
Secondary	6 Month NOSE Score	Mean change in Nose score at 6 month post-op visit	6 months
Secondary	24 Month NOSE Score	Mean change in Nose score at 24 month post-op visit	24 months