Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

University Hospital, Strasbourg, France

Status and phase: Completed; Phase 2

Conditions: Otorhinolaryngologic Diseases

Treatments: Device: Mandibular prosthesis made of a new highly biointegratable material

Study type: Interventional

Funder types: Other

Identifiers

NCT00213837

3096

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)