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| Sponsored by: |
University Hospital, Strasbourg, France |
| Information provided by: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT00213837 |
Purpose
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 |
| Official Title: | Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery |
| Estimated Enrollment: | 11 |
| 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) |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christian Debry, MD | 33388127645 | christian.debry@chru-strasbourg.fr |
| France | |||||
| Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre | Recruiting | ||||
| Strasbourg, France | |||||
| Contact: Christian Debry, MD 33.3.88.12.76.45 christian.debry@chru-strasbourg.fr | |||||
| Principal Investigator: Christian DEBRY, MD | |||||
| Sub-Investigator: Philippe SCHULTZ, MD | |||||
| Sub-Investigator: Patrick HEMAR, MD | |||||
| Sub-Investigator: Anne CHARPIOT, MD | |||||
| University Hospital, Strasbourg, France |
| 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: | 3096 |
| First Received: | September 13, 2005 |
| Last Updated: | August 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00213837 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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