Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness. (VOCALIST)
Vocal Cord Paralysis Unilateral
About this trial
This is an interventional treatment trial for Vocal Cord Paralysis Unilateral focused on measuring Type I Thyroplasty, Reinnervation
Eligibility Criteria
Inclusion Criteria:
- UVFP due to unilateral recurrent laryngeal nerve paralysis of traumatic, iatrogenic or idiopathic origin of between 6 and 60 months duration. Or symptoms that have not sufficiently improved with speech therapy alone, as determined by the patient and agreed by a multidisciplinary clinical team, after 6 months and pending a surgical decision.
- Age from 18 to 70 years old
- Male or female
- Able to provide informed consent
- A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-10 score >16)
- Common laryngeal electromyography (EMG, neurophysiological) criteria (Koufman Grades 2-5) in either the thyroarytenoid (TA) or posterior cricoarytenoid (PCA) muscle on the paralysed side.
Exclusion Criteria:
- Impaired vocal fold mobility but a normal EMG (Koufman Grade I)
- Severe lung disorders
- Structural vocal fold lesions such as polyp
- Previous laryngeal framework surgery
- Cricoarytenoid joint fixation (CAJF)
- Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
- Previous Level 2, 3 or 4 thyroid neck dissection
- Previous ipsilateral surgical neck dissection
- Previous radiotherapy to the head and neck
- Laryngeal injection of a rapidly absorbable material in the last 6 months.
- Previous laryngeal injection of a non-rapidly absorbable material (e.g. bioplastics, VOX)
- Neuromuscular disease affecting the larynx or multiple cranial nerve palsies
Sites / Locations
- Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Thyroplasty
Reinnervation
This medialisation/augmentation technique is a static technique, performed under local anaesthesia that aims to improve the positioning of the paralysed vocal fold. It uses a silastic implant readily available in different sizes according to size of larynx and gender of the patient. The correct size can be determined intraoperatively by using a measuring device while listening and visualising the larynx with flexible fiberoptic scope simultaneously.
For laryngeal reinnervation, ansa cervicalis to recurrent laryngeal nerve repair technique will be used. In this technique, the functioning ansa cervicalis nerve that overlies the internal jugular vein and the distal stump of injured recurrent laryngeal nerve (RLN) will be identified and anastomosed without tension (Crumley RL. Teflon versus thyroplasty versus nerve transfer: a comparison. The Annals of otology, rhinology, and laryngology. 1990;99(10 Pt 1):759-63).