ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution
NCT ID: NCT01147315
Last Updated: 2018-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2009-11-18
2016-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hybrid bone substitution
Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow
Hybrid bone substitution
The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis
Interventions
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Hybrid bone substitution
The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Olivier Malard, Pr
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Nantes University Hospital
Nantes, , France
Rennes University Hospital
Rennes, , France
Countries
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Other Identifiers
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BRD/08/10-H
Identifier Type: -
Identifier Source: org_study_id
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