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

Lateral Crural Strut Graft vs Bone-Anchored Suspension for Treatment of Lateral Nasal Wall Insufficiency: A Randomized Clinical Trial.

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.

Study Overview

• Status: Withdrawn
• Conditions: Nasal Valve Incompetence
• Intervention / Treatment: Procedure: Lateral Crural Strut Graft; Procedure: Bone Anchored Suspension

Detailed Description

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Division of Facial Plastics and Reconstructive Surgery, Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Lateral Crural Strut Graft; surgical technique as described; Other Names: LCSG ( lateral crural strut graft)
Active Comparator: 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.	Procedure: Bone Anchored Suspension; Surgical technique as described; Other Names: BAST(Bone Anchored Suspension technique)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NOSE (Nasal Obstruction Symptom Evaluation)score change from baseline to 12 months post op	Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific questionnaire for the assessment of Nasal Obstruction (NO)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for nasal obstruction	The scale is a 10-cm horizontal line anchored by word descriptors. It is scored by measuring the distance in millimeters from the left of where the patient's mark was placed. A higher number indicates more severe symptoms.	1 year
Visual analogue scale for satisfaction with appearance of the nose	The scale is a 10-cm horizontal line anchored by word descriptors. It is scored by measuring the distance in millimeters from the left of where the patient's mark was placed. A higher number indicates higher degree of satisfaction	1 year
physician derived lateral wall insufficiency grading system	This is a validated grading system which is measured by physician based on degrees of nasal valve insufficiency	1 year

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: SAM P Most, MD, Stanford University

Publications and helpful links

General Publications

• Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
• Tsao GJ, Fijalkowski N, Most SP. Validation of a grading system for lateral nasal wall insufficiency. Allergy Rhinol (Providence). 2013 Summer;4(2):e66-8. doi: 10.2500/ar.2013.4.0054.
• Most SP. Comparing Methods for Repair of the External Valve: One More Step Toward a Unified View of Lateral Wall Insufficiency. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):345-6. doi: 10.1001/jamafacial.2015.0790. No abstract available.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 14, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 39000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share IPD