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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01147315
First Posted: June 22, 2010
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
  Purpose
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.

Condition Intervention
Mandible Osteoradionecrosis Procedure: Hybrid bone substitution

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • The cure of ORN [ Time Frame: 12 months ]

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

Enrollment: 13
Study Start Date: November 18, 2009
Study Completion Date: November 16, 2016
Primary Completion Date: November 16, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147315


Locations
France
Nantes University Hospital
Nantes, France, 44093
Rennes University Hospital
Rennes, France, 35000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Olivier Malard, Pr Nantes University Hospital
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01147315     History of Changes
Other Study ID Numbers: BRD/08/10-H
First Submitted: June 17, 2010
First Posted: June 22, 2010
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Nantes University Hospital:
mandibular osteoradionecrosis
hybrid bone substitution
calcium-phosphate ceramic biomaterial
autologous bone marrow

Additional relevant MeSH terms:
Osteoradionecrosis
Radiation Injuries
Wounds and Injuries
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs