Implantation of Porous Titanium Prosthesis in Laryngeal Surgery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Vocal Cord Paralysis	Device: Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting	Phase II

MedlinePlus related topics:

Paralysis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:

Nasofibroscopy [ Time Frame: 8 days and 3 months after surgery ] [ Designated as safety issue: No ]
Voice control and recording [ Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial ] [ Designated as safety issue: No ]
All types of complication [ Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213863

Locations


France
	Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
	Strasbourg, France

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators


Principal Investigator:	Christian Debry, MD	Hopitaux Universitaires de Strasbourg

More Information

Responsible Party:	University Hospital, Strasbourg, France ( Emmanuel LAVOUE, Directeur Adjoint de la DRCI )
Study ID Numbers:	3097
First Received:	September 13, 2005
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00213863
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Strasbourg, France:

porous titanium implants

thyroplasty

vocal cord paralysis

male or female more than 18 years old

Study placed in the following topic categories:

Paralysis

Signs and Symptoms

Otorhinolaryngologic Diseases

Respiratory Tract Diseases

Vocal Cord Paralysis

Neurologic Manifestations

Laryngeal Diseases

Additional relevant MeSH terms:

Vagus Nerve Diseases

Nervous System Diseases

Cranial Nerve Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00213863