Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis
Primary Purpose
Otorhinolaryngologic Diseases
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Mandibular prosthesis made of a new highly biointegratable material
Sponsored by
About this trial
This is an interventional prevention trial for Otorhinolaryngologic Diseases focused on measuring porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old
Eligibility Criteria
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
Sites / Locations
- Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
Outcomes
Primary Outcome Measures
TEP scan + MRI + CT scan
Blood analysis (interleukin)
All types of complication
Secondary Outcome Measures
Full Information
NCT ID
NCT00213837
First Posted
September 13, 2005
Last Updated
February 24, 2009
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT00213837
Brief Title
Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis
Official Title
Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otorhinolaryngologic Diseases
Keywords
porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Mandibular prosthesis made of a new highly biointegratable material
Intervention Description
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.
Primary Outcome Measure Information:
Title
TEP scan + MRI + CT scan
Time Frame
3 months after surgery
Title
Blood analysis (interleukin)
Time Frame
8, 15, 30 days and 3 months after surgery
Title
All types of complication
Time Frame
8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Debry, MD
Organizational Affiliation
Hopitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
City
Strasbourg
Country
France
12. IPD Sharing Statement
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Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis
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