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Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213837
First Posted: September 21, 2005
Last Update Posted: February 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Strasbourg, France
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • TEP scan + MRI + CT scan [ Time Frame: 3 months after surgery ]
  • Blood analysis (interleukin) [ Time Frame: 8, 15, 30 days and 3 months after surgery ]
  • All types of complication [ Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial ]

Enrollment: 7
Study Start Date: October 2003
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Mandibular prosthesis made of a new highly biointegratable material
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213837


Locations
France
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
Strasbourg, France
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Christian Debry, MD Hopitaux Universitaires de Strasbourg
  More Information

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00213837     History of Changes
Other Study ID Numbers: 3096
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: February 25, 2009
Last Verified: February 2009

Keywords provided by University Hospital, Strasbourg, France:
porous titanium implants
thyroplasty
vocal cord paralysis
male or female more than 18 years old

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases