Lateral Crural Strut Graft vs Bone-Anchored Suspension for Treatment of Lateral Nasal Wall Insufficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-11-30

Brief Summary

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Lateral nasal wall insufficiency is a source of nasal obstruction which plagues many people as the sidewall of the nose collapses due to negative pressure and structural weaknesses of the nose. Bone anchored suture suspension is used by many surgeons to treat it, and involves anchoring the nasal sidewall to the bony rim below the eye. Lateral crura strut graft is another well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage. This study aims to compare the two well known and universally used treatments to each other. Based on expert opinions these procedures are both safe and efficient but given lack of randomized clinical trials comparing these 2 techniques, it is difficult to extrapolate which procedure is superior.

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Detailed Description

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Patients with lateral nasal wall collapse who are eligible for surgical repair will be presented with the opportunity to participate. Once consented, standard pre-operative evaluation will be performed including evaluation of degree of lateral nasal wall collapse. They will also be screened with validated quality of life screening tools for nasal congestion, which include the NOSE scale and a visual analog scale. They will then be randomized to treatment either with Lateral crura strut graft or bone anchored suture suspension, in combination with likely other areas of functional rhinoplasty such as septoplasty and turbinate reduction. All of our patients will be seen 1 week, 2-3 month and 1 year after surgery

Conditions

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Nasal Valve Incompetence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lateral Crural Strut Graft

Lateral crura strut graft is a well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage.

Group Type ACTIVE_COMPARATOR

Lateral Crural Strut Graft

Intervention Type PROCEDURE

surgical technique as described

Bone-Anchored suspension

Bone- Anchored suspension is a well described surgical technique which involves anchoring the nasal sidewall to the bony rim below the eye.

Group Type ACTIVE_COMPARATOR

Bone Anchored Suspension

Intervention Type PROCEDURE

Surgical technique as described

Interventions

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Lateral Crural Strut Graft

surgical technique as described

Intervention Type PROCEDURE

Bone Anchored Suspension

Surgical technique as described

Intervention Type PROCEDURE

Other Intervention Names

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LCSG ( lateral crural strut graft) BAST(Bone Anchored Suspension technique)

Eligibility Criteria

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Inclusion Criteria

\- Eligible subjects with be healthy, adults with lateral nasal wall collapse with or without septal deviation, turbinate hypertrophy, or narrowed internal nasal valve. They must have failed prior medical management with topical nasal steroid or topical or oral antihistamines. They must be able to read, sign, and demonstrate understanding of the research protocol, including agreement to randomization for treatment of their lateral nasal wall collapse

Exclusion Criteria

* All subjects shall be excluded with evidence or history of prior rhinoplasty, immunocompromise, smokers, chronic sinusitis, history of radiation to the head and neck, septal perforation, granulomatous disease, or pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes