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

Not Applicable

Completed

• Conditions: Mandible; Osteoradionecrosis
• Interventions: Procedure: Hybrid bone substitution

• Registration Number: NCT01147315
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-18
• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Primary Completion: 2016-11-16
• Study Completion: 2016-11-16
• Status Verified: 2017-05
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The cure of ORN	12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life
Number of hospital days
CT semiology description of the treated area
Bone regeneration		Bone regeneration: kinetics of formation of new bone and biomaterial resorption
Safety of hybrid bone substitution
Evaluation of post operative pain at mandibular and bone marrow sampling site
Possibility of secondary dental prosthetic devices

Trial Locations

Locations (2)

Nantes University Hospital; 🇫🇷 Nantes, France

Rennes University Hospital; 🇫🇷 Rennes, France