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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Osteoradionecrosis; Mandible

Treatments: Procedure: Hybrid bone substitution

Study type: Interventional

Funder types: Other

Identifiers

NCT01147315

BRD/08/10-H

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Hybrid bone substitution

Experimental group

Description:

Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow

Treatment:

Procedure: Hybrid bone substitution