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

April 5, 2018 updated by: Nantes University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • Nantes University Hospital
      • Rennes, France, 35000
        • Rennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid bone substitution
Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow
Procedure: Hybrid bone substitution
The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The cure of ORN
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Quality of life
Evaluation of post operative pain at mandibular and bone marrow sampling site
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Olivier Malard, Pr, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 18, 2009

Primary Completion (Actual)

November 16, 2016

Study Completion (Actual)

November 16, 2016

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 17, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/08/10-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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