ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution
ORN
10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis (ORN) Treatment
1 other identifier
interventional
13
1 country
2
Brief Summary
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2009
CompletedFirst Submitted
Initial submission to the registry
June 17, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2016
CompletedApril 6, 2018
May 1, 2017
7 years
June 17, 2010
April 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The cure of ORN
12 months
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Hybrid bone substitution
EXPERIMENTALHybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow
Interventions
The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nantes University Hospital
Nantes, 44093, France
Rennes University Hospital
Rennes, 35000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Malard, Pr
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2010
First Posted
June 22, 2010
Study Start
November 18, 2009
Primary Completion
November 16, 2016
Study Completion
November 16, 2016
Last Updated
April 6, 2018
Record last verified: 2017-05