Trial record 17 of 107 for:    Open Studies | "Jaw"

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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014