Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis
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|ClinicalTrials.gov Identifier: NCT00213837|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 25, 2009
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 or disease||Intervention/treatment||Phase|
|Otorhinolaryngologic Diseases||Device: Mandibular prosthesis made of a new highly biointegratable material||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
- Device: Mandibular prosthesis made of a new highly biointegratable material
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.
- TEP scan + MRI + CT scan [ Time Frame: 3 months after surgery ]
- Blood analysis (interleukin) [ Time Frame: 8, 15, 30 days and 3 months after surgery ]
- All types of complication [ Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213837
|Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre|
|Principal Investigator:||Christian Debry, MD||Hopitaux Universitaires de Strasbourg|