Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis - Full Text View

Purpose

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	Intervention	Phase
Otorhinolaryngologic Diseases	Device: Mandibular prosthesis made of a new highly biointegratable material	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

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

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	11
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213837

Contacts


Contact: Christian Debry, MD	33388127645	christian.debry@chru-strasbourg.fr

Locations


France
	Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre	Recruiting
	Strasbourg, France
	Contact: Christian Debry, MD 33.3.88.12.76.45 christian.debry@chru-strasbourg.fr
	Principal Investigator: Christian DEBRY, MD
	Sub-Investigator: Philippe SCHULTZ, MD
	Sub-Investigator: Patrick HEMAR, MD
	Sub-Investigator: Anne CHARPIOT, MD

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators


Principal Investigator:	Christian Debry, MD	Hopitaux Universitaires de Strasbourg

More Information

Responsible Party:	University Hospital, Strasbourg, France ( Emmanuel LAVOUE, Directeur Adjoint de la DRCI )
Study ID Numbers:	3096
First Received:	September 13, 2005
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00213837
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Strasbourg, France:

porous titanium implants

thyroplasty

vocal cord paralysis

male or female more than 18 years old

Study placed in the following topic categories:

Paralysis

Otorhinolaryngologic Diseases

Vocal Cord Paralysis

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00213837