Osteoconduction Potential of an Injectable Calcium Phosph... | NCT00206791

Studies
Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects

NCT00206791

Sponsor

Biomatlante

Status

Completed

Last Update Posted

Feb 5, 2025Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Grafting, Bone

Interventions

MBCP-Gel (tm)
MBCP Gel

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

Oct 2006

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

May 2006

Primary Completion Date

Apr 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 21, 2005Estimated

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

Feb 3, 2025

Last Update Posted Date

Feb 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes.

Detailed Description

A lot of osseous substitution products were already used to fill osseous defects in order to prevent losses of osseous that are envisaged and so prejudicial.

Synthetic calcium phosphate ceramics (particularly granulated forms) already has shown their osteoconduction potential in human at different sites. But it is difficult to put these granules in very little place.

The injectable form of calcium phosphate granules "ready to use" is easier to be used and allow a diminution of the risk of infection during surgery, and permit homogeneity of the biomaterial.

Injectable form of calcium phosphate granules did already has shown his biocompatibility and biofunctionality in animals.

The purpose of this study is to study the biocompatibility and biofunctionality of this biomaterial in his injectable form in fillings of little losses of osseous substance from various origins were no charge will act to the biomaterial.

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

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MBCPGel	Experimental		Device: MBCP-Gel (tm) Device: MBCP Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MBCP-Gel (tm)	Device	MBCPGel 5ml	MBCPGel	injectable resorbable biphasic calcium phosphate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence or absence of an edging to radiolucent on the radiographic stereotypes between the biomaterial and the osseous walls of the osseous defect at different times (3, 6 and 12 months after surgery)		3, 6 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.		3, 6 and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medium osseous defects (inferior to 20 cc) without articular communication
Patients without a personal medical history of bone infection, cancer, diabetes, tuberculosis, and in general, any pathology which could interfere with the results of the study or expose the patient to additional risk
Patients without drepanocytosis, or congenital or acquired immunizing deficit
Patients who have the benefit of a social security system, a previous medical exam and who were informed and gave free consent about this study

Exclusion Criteria:

Proven nicotinism and alcoholism
Pregnant or nursing women
Patients who received another study drug or another study device in the past 3 months or patients who will be included in another clinical study
If postoperative follow-up for a patient is considered to be random by the investigator, he/she should not be included

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
CATONNE Y, Pr.	Hôpital de la Pitié Salpétrière - 75013 PARIS - France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C		Bordeaux		33000	France

Condition Browse Module

MeSH Terms

ID	Term
D001845	Bone Cysts

Ancestor Terms

ID	Term
D003560	Cysts
D009369	Neoplasms
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided