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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01147315
• Collaborator: (none)
• Enrollment: 13
• Locations: 2
• Arm: 1
• Duration (Months): 83.9
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mandible; Osteoradionecrosis	Procedure: Hybrid bone substitution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Nov 18, 2009
• Actual Primary Completion Date: Nov 16, 2016
• Actual Study Completion Date: Nov 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. The cure of ORN [12 months]

Secondary Outcome Measures

1. Evaluation of post operative pain at mandibular and bone marrow sampling site []

2. Quality of life []

3. Possibility of secondary dental prosthetic devices []

4. CT semiology description of the treated area []

5. Bone regeneration []

   Bone regeneration: kinetics of formation of new bone and biomaterial resorption

6. Number of hospital days []

7. Safety of hybrid bone substitution []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France	44093
2	Rennes University Hospital	Rennes		France	35000

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Olivier Malard, Pr, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT01147315
• Other Study ID Numbers: BRD/08/10-H
• First Posted: Jun 22, 2010
• Last Update Posted: Apr 6, 2018
• Last Verified: May 1, 2017

• Keywords provided by Nantes University Hospital: mandibular osteoradionecrosis; hybrid bone substitution; calcium-phosphate ceramic biomaterial; autologous bone marrow
• Additional relevant MeSH terms: Osteoradionecrosis

Study Results

No Results Posted as of Apr 6, 2018