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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
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2005
Last Updated
February 24, 2009
Sponsor
University Hospital, Strasbourg, France
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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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