Clinical trial NCT03793218: Alar Batten Graft vs Latera for Nasal Valve Collapse
Official title: A Comparison of Alar Batten Graft to the Latera Nasal Implant for the Treatment of Nasal Valve Collapse
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nasal Valve Incompetence
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Portland VA Medical Center
First posted: 2019-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 12 Month NOSE Score
timeFrame: 12 months
Secondary outcomes:
measure: 1 Month NOSE Score
timeFrame: 1 month
measure: 6 Month NOSE Score
timeFrame: 6 months
measure: 24 Month NOSE Score
timeFrame: 24 months
Other outcomes:
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