Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery

NCT07579364 | Enrolling By Invitation

• 1 other identifier: 25-44455
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 10

Brief Summary

The goal of this observational study is to learn about the long-term outcomes of Laryngeal Framework Surgery (LFS) in patients with Unilateral Vocal Fold Paralysis (UVFP) or Vocal Fold Atrophy (VFA). The main questions it aims to answer are:

• Whether LFS technique (implant material, addition of arytenoid adduction) is associated with differences in outcomes such as complication rate, duration of surgery, hospital stay length, and quality of voice post-surgery.
• Whether UVFP or VFA diagnosis is associated with differences in outcomes such as complication rate, duration of surgery, hospital stay length, and quality of voice post-surgery. Participants who are determined by their clinician to need LFS for their UVFP or VFA will undergo the procedure, attend follow-up appointments, and complete surveys about their voice and swallowing ability as they would as part of their regular medical care.

Conditions

Unilateral Vocal Cord Paralysis; Vocal Cord Atrophy

Keywords

unilateral vocal fold paralysis; vocal fold atrophy; laryngeal framework surgery; arytenoid adduction; medialization thyroplasty

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the mean VHI-10 score at 12-months post operation

  Voice Handicap Index-10 is a 10-item questionnaire used to measure voice handicap. Scores range from 0-40 with higher scores indicating greater voice handicap.

  Baseline and 12 months

Study Arms (1)

Laryngeal Framework Surgery

Participants receive Laryngeal Framework Surgery, defined as medialization thyroplasty with or without arytenoid adduction.

Procedure: Laryngeal Framework Surgery

Interventions

Laryngeal Framework Surgery PROCEDURE

All participants will receive laryngeal framework surgery as recommended by their treating surgeon. This can include medialization thyroplasty with or without arytenoid adduction, under general anesthesia or monitored anesthesia care.

Also known as: medialization thyroplasty, arytenoid adduction

Laryngeal Framework Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified by treating laryngologists at the lead site (UCSF) or partner sites (Massachusetts Eye and Ear, Wake Forest, University of Cincinnati, UCSD) at the time the patient presents for their visit. If the patient is determined to have UVFP or vocal fold atrophy and is interested in undergoing surgical treatment, they will be asked about their interest in participating.

You may qualify if:

• Over 18 years of age
• Diagnosed UVFP or VFA
• English speaking
• willing and able to follow up for 2 years

You may not qualify if:

• under 18
• non-English speaking

Sponsors & Collaborators

• University of California, San Francisco: lead
• Massachusetts Eye and Ear Infirmary: collaborator
• University of California, San Diego: collaborator
• Wake Forest University: collaborator
• University of Cincinnati: collaborator
• University of Miami: collaborator
• Ohio State University: collaborator
• University of Southern California: collaborator
• Medical University of South Carolina: collaborator
• Washington University School of Medicine: collaborator

Study Sites (10)

University of California, San Diego

La Jolla, California, 92093, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27101, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (5)

• Isshiki N. Progress in laryngeal framework surgery. Acta Otolaryngol. 2000 Mar;120(2):120-7. doi: 10.1080/000164800750000748.

  PMID: 11603755 BACKGROUND

• Menon JR, Mathew AS, Nath S. Arytenoid asymmetry: Is it the most predictive parameter for arytenoid adduction in unilateral vocal fold paralysis? J Laryngol Otol. 2021 Feb;135(2):159-167. doi: 10.1017/S0022215121000475. Epub 2021 Feb 17.

  PMID: 33593469 BACKGROUND

• Siu J, Tam S, Fung K. A comparison of outcomes in interventions for unilateral vocal fold paralysis: A systematic review. Laryngoscope. 2016 Jul;126(7):1616-24. doi: 10.1002/lary.25739. Epub 2015 Oct 20.

  PMID: 26485674 BACKGROUND

• Stow NW, Lee JW, Cole IE. Novel approach of medialization thyroplasty with arytenoid adduction performed under general anesthesia with a laryngeal mask. Otolaryngol Head Neck Surg. 2012 Feb;146(2):266-71. doi: 10.1177/0194599811427811. Epub 2011 Nov 10.

  PMID: 22075075 BACKGROUND

• Mes SD, van der Jagt MA, Jansen JC, Langeveld APM, Sjogren EV, Heijnen BJ. Voice outcome in medialisation thyroplasty with and without arytenoid adduction: a prospective comparison using intraoperative voice measurements. Eur Arch Otorhinolaryngol. 2024 May;281(5):2499-2505. doi: 10.1007/s00405-024-08494-3. Epub 2024 Feb 17.

  PMID: 38365991 BACKGROUND

MeSH Terms

Conditions

Vocal Cord Paralysis

Interventions

Laryngoplasty

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Clark Rosen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: October 28, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)