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Enrolling by invitation NCT07579364

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

— Observational Unilateral Vocal Cord Paralysis Vocal Cord Atrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laryngeal Framework Surgery.
Who it may be relevant to
Registry conditions: Unilateral Vocal Cord Paralysis, Vocal Cord Atrophy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Laryngeal Framework Surgery
    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.

Primary outcome measures

  • Change from baseline in the mean VHI-10 score at 12-months post operation [Time frame: Baseline and 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 10 centers
  • University of California, San Diego — La Jolla
  • University of Southern California — Los Angeles
  • University of California, San Francisco — San Francisco
  • University of Miami — Miami
  • Massachusetts Eye and Ear Infirmary — Boston
  • Washington University in St. Louis — St Louis
  • Wake Forest University — Winston-Salem
  • University of Cincinnati — Cincinnati
  • … and 2 more centers

Publications

  • Isshiki N. Progress in laryngeal framework surgery. Acta Otolaryngol. 2000 Mar;120(2):120-7. doi: 10.1080/000164800750000748. PMID 11603755
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07579364 · 25-44455

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗