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

Primary Purpose

Mandible, Osteoradionecrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hybrid bone substitution
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandible focused on measuring mandibular osteoradionecrosis, hybrid bone substitution, calcium-phosphate ceramic biomaterial, autologous bone marrow

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital
  • Rennes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid bone substitution

Arm Description

Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow

Outcomes

Primary Outcome Measures

The cure of ORN

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2010
Last Updated
April 5, 2018
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01147315
Brief Title
ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution
Acronym
ORN
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 18, 2009 (undefined)
Primary Completion Date
November 16, 2016 (Actual)
Study Completion Date
November 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandible, Osteoradionecrosis
Keywords
mandibular osteoradionecrosis, hybrid bone substitution, calcium-phosphate ceramic biomaterial, autologous bone marrow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid bone substitution
Arm Type
Experimental
Arm Description
Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow
Intervention Type
Procedure
Intervention Name(s)
Hybrid bone substitution
Intervention Description
The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis
Primary Outcome Measure Information:
Title
The cure of ORN
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of post operative pain at mandibular and bone marrow sampling site
Title
Quality of life
Title
Possibility of secondary dental prosthetic devices
Title
CT semiology description of the treated area
Title
Bone regeneration
Description
Bone regeneration: kinetics of formation of new bone and biomaterial resorption
Title
Number of hospital days
Title
Safety of hybrid bone substitution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Malard, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

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

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