Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University Hospital, Strasbourg, France |
---|---|
Information provided by: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT00213837 |
This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity. The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.
Condition | Intervention | Phase |
---|---|---|
Otorhinolaryngologic Diseases |
Device: Mandibular prosthesis made of a new highly biointegratable material |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery |
Enrollment: | 7 |
Study Start Date: | October 2003 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre | |
Strasbourg, France |
Principal Investigator: | Christian Debry, MD | Hopitaux Universitaires de Strasbourg |
Responsible Party: | Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg ( Christine GEILLER ) |
Study ID Numbers: | 3096 |
Study First Received: | September 13, 2005 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00213837 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
porous titanium implants thyroplasty vocal cord paralysis male or female more than 18 years old |
Paralysis Otorhinolaryngologic Diseases Vocal Cord Paralysis Anesthetics |
Otorhinolaryngologic Diseases |