Status:
COMPLETED
ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution
Lead Sponsor:
Nantes University Hospital
Conditions:
Mandible
Osteoradionecrosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01147315
Start Date
November 18 2009
End Date
November 16 2016
Last Update
April 6 2018
Active Locations (2)
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1
Nantes University Hospital
Nantes, France, 44093
2
Rennes University Hospital
Rennes, France, 35000