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

Study Overview
=================
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.

Official Title
-----------------
Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins

Conditions
-----------------
Grafting, Bone

Intervention / Treatment
-----------------
* Device: MBCP-Gel (tm)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MBCP-Gel (tm)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone substitutes, Bone Replacement Materials, bone void filler, Grafting, Bone, Bone Cysts