Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

February 24, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

TEP scan + MRI + CT scan [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
Blood analysis (interleukin) [ Time Frame: 8, 15, 30 days and 3 months after surgery ] [ Designated as safety issue: No ]
All types of complication [ Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00213837 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

Official Title ^ICMJE

Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Otorhinolaryngologic Diseases

Intervention ^ICMJE

Device: Mandibular prosthesis made of a new highly biointegratable material

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00213837

Responsible Party

Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg

Study ID Numbers ^ICMJE

3096

Study Sponsor ^ICMJE

University Hospital, Strasbourg, France

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christian Debry, MD

Hopitaux Universitaires de Strasbourg

Information Provided By

University Hospital, Strasbourg, France

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP