Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis
Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedDecember 22, 2025
December 1, 2025
4.9 years
September 13, 2005
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
TEP scan + MRI + CT scan
3 months after surgery
Blood analysis (interleukin)
8, 15, 30 days and 3 months after surgery
All types of complication
8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial
Interventions
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 Criteria
You may qualify if:
- Male or female more than 18 years old
You may not qualify if:
- Age less than 18 years old
- Pregnant women
- Local carcinoma excluding radiotherapic or surgical control
- Poor general condition
- Contraindication to general anesthesia
- Uncontrolled diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
Strasbourg, France
Related Publications (1)
Schultz P, Vautier D, Atallah I, Gentine A, Debry C. [Reconstruction of the anterior mandibule using a porous titanium implant: a case report]. Rev Laryngol Otol Rhinol (Bord). 2008;129(3):201-5. French.
PMID: 19694164RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Debry, MD
Hopitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
October 1, 2003
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 22, 2025
Record last verified: 2025-12