MandibleORNNCT01147315
ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution
A study testing Hybrid bone substitution in people with Mandible and Osteoradionecrosis, run by Nantes University Hospital at 2 sites in France.
Trial summary
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mandible, Osteoradionecrosis
- What is being tested?
- Hybrid bone substitution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Nov 2009to 16 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nantes University Hospital
Nantes, 44093
Rennes University Hospital
Rennes, 35000
About this study
Official title: 10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis (ORN) Treatment
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
- Conditions
- Mandible, Osteoradionecrosis
- Being tested
- Hybrid bone substitution
- Keywords
- mandibular osteoradionecrosis, hybrid bone substitution, calcium-phosphate ceramic biomaterial, autologous bone marrow
- Medical subject headings
- Osteoradionecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid bone substitutionProcedure or surgery
The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis
| Study group | Role | What they receive |
|---|---|---|
| Hybrid bone substitution | Experimental | Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow Receives: Procedure: Hybrid bone substitution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cure of ORN
Measured: 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
Bone regeneration: kinetics of formation of new bone and biomaterial resorption
Number of hospital days
Safety of hybrid bone substitution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study start18 Nov 2009
- Primary completion16 Nov 2016
- Study completion16 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MandibleStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Malard, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147315
- Sponsor's protocol ID
- BRD/08/10-H
- Acronym
- ORN
- Status last verified
- May 2017
- First submitted
- 17 Jun 2010
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis (ORN) Treatment
- ClinicalTrials.gov ID
- NCT01147315
- Acronym / sponsor ID
- ORN / BRD/08/10-H
- Conditions
- Mandible, Osteoradionecrosis
- Keywords
- mandibular osteoradionecrosis, hybrid bone substitution, calcium-phosphate ceramic biomaterial, autologous bone marrow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Nov 2009
- Primary completion
- 16 Nov 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid bone substitution | Experimental | Procedure: Hybrid bone substitutionHybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid bone substitutionThe patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis | Procedure or surgery | Hybrid bone substitution |
Primary outcome
The cure of ORN
Time frame: 12 months
7 secondary outcomes
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
Number of hospital days
Safety of hybrid bone substitution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Malard, Pr principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid bone substitution in people with Mandible and Osteoradionecrosis, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cure of ORN (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.