Vocal Cord Paralysis
Conditions
Keywords
porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old
Brief summary
This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery.
Interventions
DEVICEVocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting
The porous titanium prosthesis is implanted under local anaesthesia. Neck incision is performed in order to expose the thyroidal cartilage. A window is then opened in this cartilage, and the implant is placed in contact with the vocal muscles. The patient is then asked to speak in order to achieve the implant best setting.
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females greater than 18 years old
Exclusion criteria
* Age less than 18 years * Pregnant women * Local carcinoma excluding radiotherapeutic or surgical control * Bad general condition * Contraindication to general anesthesia * Non-controlled diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasofibroscopy | 8 days and 3 months after surgery |
| Voice control and recording | 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial |
| All types of complication | 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial |
Countries
France
Contacts
Primary ContactChristian Debry, MD
Outcome results
None listed