Laryngeal Reinnervation Versus Thyroplasty in Patients With Vocal Fold Weakness.

NCT02973152 | Completed Phase 2

• 2 other identifiers: 11/0107PB-PG-1013-32058
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to help determine the most effective treatment for participants with Unilateral Vocal Fold Paralysis. There are currently two types of operations used to treat this condition. One operation is called thyroplasty. Doctors place a small piece of safe plastic into the side of the participant's voice box to push the weak vocal cord into a position to enable better speech and swallowing. In the other operation called laryngeal reinnervation, doctors repair the neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better speech and swallowing. The investigators do not know which of these methods is better and are conducting this study to start comparing the two operations so that a larger clinical trial can be conducted in the future to tell us which operation is best.

Conditions

Vocal Cord Paralysis Unilateral

Keywords

Type I Thyroplasty; Reinnervation

Outcome Measures

Primary Outcomes (3)

• Whether the participant was randomised (yes/no)

  From those participants who were eligible to enter the study, whether the participant was randomised (yes/no)

  24 months

• Whether the participant successfully received the allocated operation (yes/no)

  From those participants who were eligible to enter the study, whether the participant successfully received the allocated operation (yes/no)

  24 months

• Whether the participant completed the trial (yes/no)

  From those participants who were eligible to enter the study, whether the participant completed the trial (yes/no)

  24 months

Secondary Outcomes (15)

• Whether the Study Management Group (SMG) and recruiters are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews.

  24 months

• Whether surgeons and speech therapists are in clinical equipoise in relation to treatment arms (yes/no) measured by Qualitative researcher via interviews. between the two treatments

  24 months

• Patient views and beliefs on randomisation, recruitment and retention measured by Qualitative researcher via interviews. processes

  24 months

• Patient and surgeon/speech therapist views on utility of chosen outcome measure measured by Qualitative researcher via interviews. measures

  24 months

• Interaction between recruiter and patient during recruitment process measured by Qualitative researcher via interviews.

  24 months

Study Arms (2)

Thyroplasty

ACTIVE COMPARATOR

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.

Procedure: Thyroplasty

Reinnervation

ACTIVE COMPARATOR

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).

Procedure: Reinnervation

Interventions

Thyroplasty PROCEDURE

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.

Thyroplasty

Reinnervation PROCEDURE

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).

Reinnervation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal National Throat, Nose and Ear Hospital: lead
• University College Joint Research Office: collaborator
• University College London Hospitals: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Sealed Envelope: Redpill Online Application: collaborator

Study Sites (1)

Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road

London, WC1X 8DA, United Kingdom

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Interventions

Laryngoplasty

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Professor Martin Birchall, FRCS,FMedSci

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 25, 2016
• Study Start: May 1, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 29, 2018

Record last verified: 2018-05

Locations

GB (1)