Unilateral Vocal Cord Paralysis Clinical Trial
Official title:
Medialization Vs Reinnervation for Vocal Cord Paralysis
Unilateral vocal fold paralysis (UVFP) is caused by injury to the nerve to the affected
vocal fold. The injury to the vocal fold makes the affected person's voice sound "breathy".
Voice therapy is usually tried first, and, if unsuccessful, surgical treatment is
considered. The standard surgical treatment is called vocal fold medialization and aims to
bring the injured cord to the midline. An alternative surgical treatment, vocal fold
reinnervation, aims to bring a new nerve supply to the injured vocal fold. The reinnervation
operation, which has some potential advantages over the medialization operation also
requires several months for final results to be gained. The goal of this multicenter,
randomized clinical trial is to see which of the two surgical treatments produces a better
outcome.
In order to participate in this study patients with UVFP must meet all entry criteria and
must be released from voice therapy by a speech-language pathologist. Information collected
for the study (pre-surgery, and at 6 and 12 months after surgery) includes voice recordings,
movies made of vocal fold function, airflow and pressure measurements of the voicebox, and
an outcomes questionnaire.
Unilateral vocal fold paralysis (UVFP) is caused by injury to the recurrent laryngeal nerve.
Patients with UVFP may have significant impairment of vocal fold function, including a
breathy paralytic dysphonia. There are several available approaches for the treatment of
this condition. Vocal fold medialization is currently used by most otolaryngologists and is
probably the standard of care for treating UVFP. An alternative approach is laryngeal
reinnervation, which has a number of potential advantages over medialization but which
requires several months before a final result is achieved. The primary goal of this
multicenter, randomized clinical trial is to determine which approach produces a better
outcome.
Patients with UVFP meeting all inclusion criteria and released from therapy by a
speech-language pathologist will be randomized into either the medialization arm or the
reinnervation arm. The data collection protocol consists of voice recordings, aerodynamic
measurements, electroglottography, videostroboscopy, and a clinical outcomes questionnaire
collected pre-treatment and at 6 and 12 months post-treatment.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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