ORN Study: Curative Treatment of Osteoradionecrosis (ORN)... | NCT01147315

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

NCT01147315

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Apr 6, 2018Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Mandible
Osteoradionecrosis

Interventions

Hybrid bone substitution

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2009

Primary Completion Date

Nov 16, 2016Actual

Completion Date

Nov 16, 2016Actual

First Submitted Date

Jun 17, 2010

First Submission Date that Met QC Criteria

Jun 17, 2010

First Posted Date

Jun 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2018

Last Update Posted Date

Apr 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hybrid bone substitution	Experimental	Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow	Procedure: Hybrid bone substitution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hybrid bone substitution	Procedure	The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The cure of ORN		12 months

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of post operative pain at mandibular and bone marrow sampling site
Quality of life
Possibility of secondary dental prosthetic devices

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier Malard, Pr	Nantes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes		44093	France
Rennes University Hospital

ID	Term
D011832	Radiation Injuries
D014947	Wounds and Injuries