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Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

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ClinicalTrials.gov Identifier: NCT00213837
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 25, 2009
Sponsor:
Information provided by:
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Otorhinolaryngologic Diseases Device: Mandibular prosthesis made of a new highly biointegratable material Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Study Start Date : October 2003
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine



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.


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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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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

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 Posted: September 21, 2005    Key Record Dates
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