ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution

Study Overview
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Brief Summary
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The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.

Official Title
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10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis (ORN) Treatment

Conditions
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Mandible, Osteoradionecrosis

Intervention / Treatment
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* Procedure: Hybrid bone substitution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid bone substitution<br>Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow | Procedure: Hybrid bone substitution<br>* The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cure of ORN |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of post operative pain at mandibular and bone marrow sampling site |  |  | 
| Quality of life |  |  | 
| Possibility of secondary dental prosthetic devices |  |  | 
| CT semiology description of the treated area |  |  | 
| Bone regeneration | Bone regeneration: kinetics of formation of new bone and biomaterial resorption |  | 
| Number of hospital days |  |  | 
| Safety of hybrid bone substitution |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mandibular osteoradionecrosis, hybrid bone substitution, calcium-phosphate ceramic biomaterial, autologous bone marrow