Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis
Phase 2
Completed
- Conditions
- Otorhinolaryngologic Diseases
- Registration Number
- NCT00213837
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- Male or female more than 18 years old
Exclusion Criteria
- Age less than 18 years old
- Pregnant women
- Local carcinoma excluding radiotherapic or surgical control
- Poor general condition
- Contraindication to general anesthesia
- Uncontrolled diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
🇫🇷Strasbourg, France