Functional Effect of Treatment of Glottic Insufficiency With Calcium Hydroxyapatite
Information source: University Hospital Ostrava
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glottic Insufficiency
Intervention: Calcium Hydroxyapatite (Procedure); Radiesse Voice (Calcium Hydroxyapatite) (Device)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital Ostrava Official(s) and/or principal investigator(s): Radana Walderová, MD, Principal Investigator, Affiliation: University Hospital Ostrava
Overall contact: Vaclav Prochazka, MD,PhD,MSc, Phone: +42059737, Ext: 2510, Email: vaclav.prochazka@fno.cz
Summary
The voice is an indispensable source of human communication. Current time puts high demands
on the quality of voice in most professions. Organic or functional changes of vocal cords
associated with their insufficiency lead to a deterioration of voice quality, voice fatigue,
hoarseness or breathing difficulties. This has adverse psychological, social and economic
consequences for the patient, the employer and its surroundings. The injection techniques
can be performed under general and local anaesthesia. The defined injectable substance is
inserted directly in the vocal cords, which increases its volume and results in an almost
immediate improvement of the voice quality. For injection can be used various materials,
e. g. autologous fat, calcium hydroxyapatite, silicone, and others. Injection techniques are
less invasive, associated with less perioperative morbidity. Operation can be also performed
under local anaesthesia in selected patients, therefore is preferred for patients with
multiple comorbidities and risk of general anaesthesia.
Clinical Details
Official title: Assessment of the Functional Effect of Treatment of Glottic Insufficiency With Injection Technique With the Use of Calcium Hydroxyapatite
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Objective improvement of voice parameters
Secondary outcome: Endoscopic assessment
Detailed description:
The causes of glottic insufficiency (vocal fold insufficiency) may be paresis (immobility)
of one or both vocal folds (of iatrogenic aetiology after thyroid surgery, neck operations
or ingrowth of malignant tumours of the chest or mediastinum, idiopathic after viral
infections or central neuropathy) and atrophy (loss of mass) of the vocal cords, which
particularly affect older patients. Surgical treatment of insufficiency is indicated for
patients in whom conservative treatment is ineffective.
Surgical treatment of vocal fold insufficiency is carried out in two ways:
- By thyroplasty type I, operations performed mostly under general anaesthesia, by the
external access to the neck with the insertion of a silicone block through the thyroid
cartilage into the space next to the vocal cords, which moves it medially.
- Augmentation of the vocal cords, at which an insertion of an own (fat, cartilage, etc.)
or a foreign (Gore-Tex, silicone, etc.) material laterally from the vocal cords can
facilitate a change in the position of the vocal cords. In recent years, more and more
so-called augmentation injection techniques are preferred.
While thyroplasty has been carried out in the Czech Republic for 10-15 years, the clinicians
have had only limited experience with the injection techniques, which has been used for
several years only and information about the functional results are still insufficient to
date.
The working hypotheses
- Augmentation of vocal folds with hydroxyapatite leads to significant improvements in
subjective and objective parameters of voice
- Augmentation of vocal folds with hydroxyapatite is a method comparable with other
methods of treatment of glottic insufficiency (thyroplasty type 1, vocal folds
augmentation with autologous fat)
- Augmentation of vocal folds with hydroxyapatite can be performed under local
anaesthesia The objective of the study is to determine the functional effect of
augmented vocal folds with calcium hydroxyapatite ("Radiesse Voice") by comparing
selected defined parameters preoperatively and postoperatively.
Other anticipated benefits of the study treatment include improving the quality of life of
patients (improved voice quality, breathing, improve of mental state, preventing of social
isolation and economic consequences). It will also lead to the introduction of new
processes, materials and methods. It is also possible to expect shortening of the hospital
stay, decrease in postoperative morbidity, and the possibility to perform the procedure on
an outpatient basis.
The study has been designed as a prospective study, which is in conformity with the
principles and guidelines of the Helsinki Declaration, good clinical practice and has been
approved by the Ethical Committee of the University Hospital Ostrava.
The patients enrolled in the study will be followed for the period of twelve months.
Timetable of the study procedures and controls:
Preoperative examination:
- Demographic data on age, sex, weight, height, smoking, cause of insufficiency
- Questionnaires Voice Handicap Index (VHI)
- Stroboscopy examination (assessment of the size of insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia,
Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice
range
Examination 3 months postoperatively
- Questionnaires Voice Handicap Index (VHI)
- High-speed laryngoscopy, stroboscopy and videokymography (assessment of the size of
insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia,
Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice
range
Examination 6 months after surgery
- Questionnaires Voice Handicap Index (VHI)
- High-speed laryngoscopy, stroboscopy and videokymography (assessment of the size of
insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia,
Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice
range.
Examination 12 months after surgery (optional examination with cooperative patients)
- Questionnaires Voice Handicap Index (VHI)
- High-speed laryngoscopy, stroboscopy and videokymography (assessment of the size of
insufficiency)
- Voice Analysis (Vospector Program - Breathable, Hoarseness, total grade of dysphonia,
Maximum Phonation time, Dysphonia Severity Index - based on examination of the voice
range.
Statistical data processing For statistical evaluation descriptive statistics will be used
(arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test,
analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence
intervals, and logistic regression. Statistical tests will be evaluated at the significance
level of 5%. Statistical analysis will be performed in the "Stata 10" programme. Program MS
Excel will be used for data collection.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18-70 years
- Insufficiency caused by paresis or atrophy
- Duration of insufficiency of at least six months
- Size of the insufficiency not exceeding three millimetres
- Signing of the informed consent
Exclusion Criteria:
- Size of the insufficiency exceeding three millimetres
Locations and Contacts
Vaclav Prochazka, MD,PhD,MSc, Phone: +42059737, Ext: 2510, Email: vaclav.prochazka@fno.cz
University Hospital Ostrava, Ostrava 708 52, Czech Republic; Recruiting Jiri Hyncica, Bc., Phone: +420597372510, Email: jiri.hyncica@fno.cz Vaclav Prochazka, MD,PhD,MSc, Phone: +420597372544, Email: angio@vol.cz Radana Walderová, MD, Principal Investigator Pavel Komínek, Prof,MD,PhD, Sub-Investigator Karol Zeleník, MD, PhD, Sub-Investigator
Additional Information
Starting date: April 2014
Last updated: May 28, 2015
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