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Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

This study has been completed.
Information provided by:
University Hospital, Strasbourg, France Identifier:
First received: September 13, 2005
Last updated: February 24, 2009
Last verified: February 2009

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00213837

Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
Strasbourg, France
Sponsors and Collaborators
University Hospital, Strasbourg, France
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 Identifier: NCT00213837     History of Changes
Other Study ID Numbers: 3096
Study First Received: September 13, 2005
Last Updated: February 24, 2009

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

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases processed this record on September 21, 2017