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

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.

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Key information

Conditions

Unilateral Vocal Cord Paralysis Cranial Nerve Diseases Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases Vocal Cord Atrophy Vocal Cord Paralysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Diego, La Jolla, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

under 18
non-English speaking

Treatment and study plan

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.

Other names: medialization thyroplasty, arytenoid adduction

Primary outcomes

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

Time frame: Baseline and 12 months

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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: May 12, 2026
Registry last updated: May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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