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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular prosthesis made of a new highly biointegratable material | Device | Replacement of mandibular bone after partial or total mandible resection,avoiding then bone grafting. The porous titanium prosthesis is implanted under general anaesthesia in laryngeal surgeries. Bone resection and prosthesis placement is performed during the same surgical intervention. The prosthesis is attached onto the healthy bone with surgical screws. Simultaneous grafting of vascularised tissues may be done if the prosthesis surrounding area has been strongly irradiated. |
| Measure | Description | Time Frame |
|---|---|---|
| TEP scan + MRI + CT scan | 3 months after surgery | |
| Blood analysis (interleukin) | 8, 15, 30 days and 3 months after surgery | |
| All types of complication | 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Debry, MD | Hopitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre | Strasbourg | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19694164 | Result | Schultz P, Vautier D, Atallah I, Gentine A, Debry C. [Reconstruction of the anterior mandibule using a porous titanium implant: a case report]. Rev Laryngol Otol Rhinol (Bord). 2008;129(3):201-5. French. |
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| ID | Term |
|---|---|
| D010038 | Otorhinolaryngologic Diseases |
| D014826 | Vocal Cord Paralysis |
| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D020421 | Vagus Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
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| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |