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

This study is currently recruiting participants.
Verified November 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01147315
First received: June 17, 2010
Last updated: November 6, 2013
Last verified: November 2013
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of post operative pain at mandibular and bone marrow sampling site [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Possibility of secondary dental prosthetic devices [ Designated as safety issue: No ]
  • CT semiology description of the treated area [ Designated as safety issue: No ]
  • Bone regeneration [ Designated as safety issue: No ]
    Bone regeneration: kinetics of formation of new bone and biomaterial resorption

  • Number of hospital days [ Designated as safety issue: No ]
  • Safety of hybrid bone substitution [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: November 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147315

Contacts
Contact: Olivier Malard, Pr +33 2 40 08 34 73 omalard@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Olivier Malard, Pr    +33 2 40 08 34 73    omalard@chu-nantes.fr   
Rennes University Hospital Recruiting
Rennes, France, 35000
Contact: Franck Jégoux, Dr    +33 2 99 28 42 85      
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Olivier Malard, Pr Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01147315     History of Changes
Other Study ID Numbers: 08/10-H
Study First Received: June 17, 2010
Last Updated: November 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on April 17, 2014