Mandible, Osteoradionecrosis
Conditions
Keywords
mandibular osteoradionecrosis, hybrid bone substitution, calcium-phosphate ceramic biomaterial, autologous bone marrow
Brief summary
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
Interventions
PROCEDUREHybrid bone substitution
The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (between 18 and 75 years) affiliated with an appropriate social security system, diagnosed as suffering from symptomatic ORN, radiologically confirmed, for which surgery is indicated * Presence maximum of 2 outbreaks of ORN * Oncological remission of the original tumor site for 1 year and for 3 years if the ORN is in the contact or close to the initial tumoral site * ECOG performance status 0, 1 or 2 * ORN symptomatic accessible to the conservation of at least one cortical mandibular basilar * Signed informed consent
Exclusion criteria
* Oncological treatment * Haematologic background * Current bone necrosis consecutive or concurrent to taking bisphosphonates * Extension of ORN does not allow the retention of a mandibular rod (bicortical form) * Presence of fracture complicating ORN * Bisphosphonates during the last year * Contraindications to the removal of iliac or sternum bone marrow * Contraindication for general anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cure of ORN | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | — | — |
| Possibility of secondary dental prosthetic devices | — | — |
| CT semiology description of the treated area | — | — |
| Evaluation of post operative pain at mandibular and bone marrow sampling site | — | — |
| Number of hospital days | — | — |
| Safety of hybrid bone substitution | — | — |
| Bone regeneration | — | Bone regeneration: kinetics of formation of new bone and biomaterial resorption |
Countries
France
Outcome results
None listed