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| Name | Class |
|---|---|
| Massachusetts Eye and Ear Infirmary | OTHER |
| University of California, San Diego | OTHER |
| Wake Forest University | OTHER |
| University of Cincinnati |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laryngeal Framework Surgery | Participants receive Laryngeal Framework Surgery, defined as medialization thyroplasty with or without arytenoid adduction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clark Rosen, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11603755 | Background | Isshiki N. Progress in laryngeal framework surgery. Acta Otolaryngol. 2000 Mar;120(2):120-7. doi: 10.1080/000164800750000748. | |
| 33593469 | 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. |
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| OTHER |
| University of Miami | OTHER |
| Ohio State University | OTHER |
| Washington University School of Medicine | OTHER |
| University of Southern California | OTHER |
| Medical University of South Carolina | OTHER |
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|
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27101 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| 26485674 | 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. |
| 22075075 | 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. |
| 38365991 | 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. |
| ID | Term |
|---|---|
| D014826 | Vocal Cord Paralysis |
| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020421 | Vagus Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058753 | Laryngoplasty |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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