Functional Effect of Treatment of Glottic Insufficiency With Calcium Hydroxyapatite
Condition: Glottic Insufficiency
Study type: Interventional

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.
    

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.
    

Intervention name(s): Calcium Hydroxyapatite; Radiesse Voice (Calcium Hydroxyapatite)
Intervention type(s): Procedure; Device
Intervention description(s): Surgical augmentation of the vocal cords with injection of calcium hydroxyapatite
Other intervention name(s): Radiesse Voice
Intervention MeSH terms: Calcium, Dietary; Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glottic insufficiency; calcium hydroxyapatite; augmentation of vocal cords with injection technique