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

Osteoradionecrosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147315
• Other study ID #: BRD/08/10-H
• Status: Completed
• Phase: N/A
• First received: June 17, 2010
• Last updated: April 5, 2018
• Start date: November 18, 2009
• Est. completion date: November 16, 2016

Study information

• Verified date: May 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 16, 2016
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mandible
• Osteoradionecrosis

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cure of ORN		12 months
Secondary	Evaluation of post operative pain at mandibular and bone marrow sampling site
Secondary	Quality of life
Secondary	Possibility of secondary dental prosthetic devices
Secondary	CT semiology description of the treated area
Secondary	Bone regeneration	Bone regeneration: kinetics of formation of new bone and biomaterial resorption
Secondary	Number of hospital days
Secondary	Safety of hybrid bone substitution