Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

Otorhinolaryngologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213837
• Other study ID #: 3096
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: February 24, 2009
• Start date: October 2003
• Est. completion date: September 2008

Study information

• Verified date: February 2009
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Otorhinolaryngologic Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEP scan + MRI + CT scan		3 months after surgery	No
Primary	Blood analysis (interleukin)		8, 15, 30 days and 3 months after surgery	No
Primary	All types of complication		8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial	Yes