Alar Batten Graft vs Latera for Nasal Valve Collapse

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Nasal Valve Incompetence
• Intervention / Treatment: Device: Latera Device; Procedure: Alar Batten Graft

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John J Christophel, MD, MPH; Phone Number: 434-243-9391; Email: JJC3Y@hscmail.mcc.virginia.edu
• Study Contact Backup: Name: Michael Dougherty, BA; Email: mid5kb@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Latera Device; The LATERA (Spirox Inc., Menlo Park, CA) device, an absorbable nasal implant comprised of a 70:30 blend of poly(L-lactide) and poly(D-lactide), is designed to provide support to the upper and lower lateral cartilages, thereby correcting nasal wall collapse. The implant was first used in the US and cleared by the FDA in 2016. It is designed as a ribbed cylindrical structure with a forked distal end. The implant is delivered endonasally, with a 16-gauge catheter, lateral to the upper and lower lateral cartilages and over the ascending process of the maxilla. The forked end rests on the ascending process of the maxilla and the flexible implant provides support the nasal sidewall soft tissue and cartilage. This non-toxic, biocompatible co-polymer has an extensive use in a variety of medical devices including suture materials and implants. In vivo studies demonstrate the copolymer to reliably decompose over an 18-24 month period.	Device: Latera Device; This study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant
Active Comparator: Alar Batten Graft; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 Month NOSE Score	Mean change in Nose score at 12 month post-op visit	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 Month NOSE Score	Mean change in Nose score at 1 month post-op visit	1 month
6 Month NOSE Score	Mean change in Nose score at 6 month post-op visit	6 months
24 Month NOSE Score	Mean change in Nose score at 24 month post-op visit	24 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Portland VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 20859

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No