Assessment of the Functional Effect of Treatment of Glottic Insufficiency With Injection Technique With the Use of Calcium Hydroxyapatite
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Objective improvement of voice parameters
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Size of the insufficiency exceeding three millimetres
研究组 & 干预措施
Calcium Hydroxyapatite
30 patients with glottic insufficiency treated operatively with augmentation of vocal cords with injection technique
干预措施: Calcium Hydroxyapatite (Procedure)
Calcium Hydroxyapatite
30 patients with glottic insufficiency treated operatively with augmentation of vocal cords with injection technique
干预措施: Radiesse Voice (Calcium Hydroxyapatite) (Device)
结局指标
主要结局
Objective improvement of voice parameters
时间窗: 32 months
irregularity, noise, overall severity, jitter, shimmer, GNE
次要结局
- Endoscopic assessment(32 months)