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

NCT03131115 | Withdrawn DMC

• 1 other identifier: 39000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasal Valve Incompetence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual Analogue Scale for nasal obstruction

  1 year

• Visual analogue scale for satisfaction with appearance of the nose

  1 year

• physician derived lateral wall insufficiency grading system

  1 year

Study Arms (2)

Lateral Crural Strut Graft

ACTIVE COMPARATOR

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

Bone-Anchored suspension

ACTIVE COMPARATOR

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

Interventions

Lateral Crural Strut Graft PROCEDURE

surgical technique as described

Also known as: LCSG ( lateral crural strut graft)

Lateral Crural Strut Graft

Bone Anchored Suspension PROCEDURE

Surgical technique as described

Also known as: BAST(Bone Anchored Suspension technique)

Bone-Anchored suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Division of Facial Plastics and Reconstructive Surgery, Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (3)

• 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.

  PMID: 14990910 BACKGROUND

• 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.

  PMID: 24124639 BACKGROUND

• 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.

  PMID: 26247486 BACKGROUND

Study Officials

• Sam P Most, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Facial Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)